Orbit The International Journal on Orbital Disorders, Oculoplastic and Lacrimal Surgery
ISSN: 0167-6830 (Print) 1744-5108 (Online) Journal homepage: http://www.tandfonline.com/loi/iorb20
Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi Esther Lee Kim, Carlo Rob Bernardino & Flora Levin To cite this article: Esther Lee Kim, Carlo Rob Bernardino & Flora Levin (2016): Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi, Orbit, DOI: 10.3109/01676830.2016.1139593 To link to this article: http://dx.doi.org/10.3109/01676830.2016.1139593
Published online: 29 Feb 2016.
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Date: 08 March 2016, At: 08:12
ORBIT 2016, VOL. 0, NO. 0, 1–6 http://dx.doi.org/10.3109/01676830.2016.1139593
CLINICAL RESEARCH
Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi Esther Lee Kima,b, Carlo Rob Bernardino,c and Flora Levinb
Downloaded by [Orta Dogu Teknik Universitesi] at 08:12 08 March 2016
a Department of Ophthalmology, University of Southern California Eye Institute, Los Angeles, California, USA; bDepartment of Ophthalmology & Visual Science, Yale Eye Center, New Haven, Connecticut, USA; cOculoplastics and Aesthetic Surgery, Vantage Eye Center, Monterey, California, USA
ABSTRACT
ARTICLE HISTORY
The purpose of this study is to describe our experience using expandable spherical hydrogel implants and injectable hydrogel pellets for orbital volume augmentation in cases of postenucleation socket syndrome after acquired anophthalmia or phthisis bulbi. We retrospectively reviewed the clinical records of all adult patients who received an expandable hydrogel implant for orbital volume loss following enucleation or phthisis bulbi at the Emory Eye Center between 2004 and January 2007 and the Yale Eye Center between 2009 and 2011. The study included 9 women and 5 men with a mean age of 51.2 years old (range 35-76 years old). Follow-up spanned 6 to 71 months (median of 18.5 months). Four patients received spherical hydrogel implants and 10 patients received hydrogel pellet injections. On average, nine pellets (range 5-16) were placed in each patient over an average of 1.7 injections (range 1-3). Most commonly, five pellets were injected per session, as was the case for 13 of the 17 treatment sessions. Post-operative complications included 2 cases of pellet migration, one subcutaneously and one anteriorly due to insufficiently posterior implant placement, and 1 hospital admission for pain after injection of 10 pellets in one visit. All patients experienced an overall subjective improvement in cosmesis. Self-expandable hydrogel implants appear to offer several advantages over other existing options for orbital volume augmentation, as they are easy to place, generally well-tolerated, volumetitratable, and to the extent that our follow-up shows, may be a safe and durable means of treating orbital volume loss in patients with acquired anophthalmia and phthisis bulbi.
Received 23 November 2014 Accepted 4 January 2016
Introduction Insufficient orbital volume following enucleation or evisceration can result in post-enucleation socket syndrome (PESS), characterized by enophthalmos, a deep superior sulcus, ptosis or eyelid retraction, lower eyelid laxity, and poor prosthesis functioning.1 Longstanding phthisis can result in orbital volume deficiency similar to PESS. Patients with PESS fit into one of two categories: those without an orbital implant or those with an inadequately sized orbital implant and/or with surrounding volume loss. Patients in the former category can achieve volume augmentation with a secondary spherical orbital implant or a dermis fat graft. Those in the latter category may undergo implant exchange, enophthalmic wedge placement, soft-tissue fillers, or autologous tissue implants including fat grafts. In patients with phthisis, a thick scleral shell can be worn over the phthisical eye, or if not tolerated due to size or fit, an enucleation or
KEYWORDS
Anophthalmia; hydrogel; implants; phthisis bulb
evisceration can be performed with placement of appropriate implant. There continues to be little consensus regarding the choice of orbital implant material and design. Many of the existing volume augmentation techniques have significant drawbacks, as they may be costly, temporary, or lengthy procedures carrying additional risks, such as donor site morbidity. The ideal implant would be one that is easy to place, biocompatible, volume-titratable, predictable, long-lasting, non-toxic, and cost-effective. Hydrogel (copolymer of methylmethacrylate and N-vinylpyrrolidone) is a highly hydrophilic, selfexpanding material previously used in soft contact lenses and scleral buckles,2,3 Dehydrated, the material is small and solid, thereby allowing easy insertion into the socket. Hydrated, the implants swell to become a pliable, gelatin-like material up to 12 times the original volume.4,5 Hydrogel implants are available in three shapes for different purposes: spheres, hemispheres
CONTACT Esther Lee Kim [email protected] Department of Ophthalmology, University of Southern California Eye Institute, 1450 San Pablo St, Suite 4900, Los Angeles, California 90033, USA. Color versions for one or more of the figures in the article can be found online at www.tandfonline.com/iorb. © 2016 Taylor & Francis
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and pellets. A sphere may be used for bony orbital expansion in congenital cases or as a secondary implant for volume augmentation and improved prosthesis fitting and function. A hemisphere may be used for socket and palpebral fissure expansion, while pellets allow for orbital volume augmentation in the case of an existing implant or globe. The implants exert a constant hydrostatic pressure of 20–30 mmHg as they swell. According to the manufacturer, the bony orbital expansion may take six months for full effect. Hydrogel implants have been used successfully for congenital anophthalmia and microphthalmia, with an average follow-up period of 9.7 months.6–11 However, to the best of our knowledge, their use has not been reported following acquired anophthalmia or phthisis bulbi. In this study, we present our initial experience using the sphere and pellet hydrogel implants in 14 patients with orbital volume loss from acquired anophthalmia or phthisis. Furthermore, we provide a longer follow-up period than previously reported, with an average of 15.8 months’ follow-up for spheres and 26.3 months for pellet injections.
photographs were analyzed. All study procedures were compliant with the Health Insurance Portability and Accountability Act and the Declaration of Helsinski for research involving human participants.
Surgical technique: Spherical implant Spherical hydrogel implants (Figure 1a) are available in four final volumes—2.0, 3.0, 4.0, and 5.0 ml. Placement of spherical hydrogel implants is performed in the operating room under intravenous sedation with a retrobulbar block or general anesthesia. After a lid speculum is placed, a small, 1-cm lateral canthal incision is made, and the lateral orbital rim periosteum is bluntly dissected deep into the orbit. After visualizing the intraconal space, the rectus muscles and/or the optic nerve are palpated to confirm location. A dehydrated hydrogel sphere is then pushed into the deep orbit. An anterior transconjunctival approach can also be used in lieu of the lateral orbitotomy approach. Tenons is closed with 5-0 polyglactin suture in a buried fashion, and the conjunctiva with 6-0 fast-absorbing gut suture. A conformer is then placed in the conjunctival socket.
Material and methods We retrospectively reviewed the clinical records of all patients who received an expandable hydrogel orbital implant (Osmed hydrogel tissue expanders, IOP Inc., Costa Mesa, CA) for orbital volume loss following enucleation or phthisis bulbi at Emory Clinic between 2003 and January 2007 and the Yale Eye Center between 2009 and 2011. Three patients with incomplete data were excluded from the study. The data collected included gender, age at the time of implantation, previous ophthalmic conditions, type of hydrogel implant, number of pellets and injections required, follow-up time, and complications. Outcome measures were postoperative appearance, prosthesis function, and procedurerelated complications. Preoperative and postoperative
Surgical technique: Pellet implant Pellet hydrogel implants (Figure 1b) are 0.2 ml each in final volume. Unlike the spherical hydrogel implants, which require placement in the operating room, hydrogel pellets can be placed under local anesthesia in an office setting. Lidocaine 2% with epinephrine 1:100,000 was instilled as a retrobulbar block. The final result was anticipated by the volume augmentation effect produced by the amount of local anesthetic solution injected in the orbital apex region. The included trocar is inserted transcutaneously along the orbital floor and directed posterior to the orbital implant or phthisical globe (Figures 2a and 2b). The pellets are placed deep
Figure 1. Hydrogel implants pre- and post-hydration. (a) Sphere, (b) pellet.
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No orbital implant Four patients received a secondary spherical hydrogel implant. One patient required a 3.0-ml implant, two patients required 4.0-ml implants, and one patient required a 5.0-ml implant. The follow-up period ranged from 8 to 30 months, with an average follow-up time of 15.8 months. In all 4 cases, there were no infections or extrusions over the follow-up periods. All patients had subjective cosmetic improvement and were successfully fit with prostheses.
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Enophthalmos
Figure 2. Hydrogel pellet injection. (a) and (b) Trocar is introduced transcutaneously just above the orbital rim. (c) Hydrogel pellets are placed via the cannula.
into the socket (Figure 2c), and the volume is adjusted by the number of implants placed.
Results Fourteen patients received hydrogel implants, including 9 females and 5 males. Average age at the time of implantation was 51.2 years old, with ages ranging from 35 to 76 years old. Four patients received spherical hydrogel implants, and 10 patients underwent hydrogel pellet injections.
Ten patients were treated with injectable hydrogel pellets for enophthalmos. Eight patients had acquired anophthalmia with prior placement of a primary orbital implant and two patients had a phthisical globe. An average of 9 pellets (range 5–16) were placed in each patient over an average of 1.7 injections (range 1–3). Most commonly, five pellets were injected per session, as was the case for 13 of the 17 total treatment sessions. The most number of pellets placed in one sitting was 10 in one patient. The follow-up period ranged from 6 to 71 months, with an average follow-up time period of 26.3 months. There were no signs of infection, rejection, extrusion, or inflammation attributable to the pellets during the follow-up period. There were two cases of pellet migration, both due to insufficiently posterior placement of the implants into the deep orbit. One patient required removal of one pellet that migrated subcutaneously. Another patient with five implants placed initially had anterior migration of several pellets two weeks following insertion, requiring removal of 4 pellets. This patient had 5 additional pellets inserted less than 4 months later with a good final outcome. The one patient who had 10 pellets placed in one setting had postoperative pain and vomiting, which required hospitalization. The patient was hospitalized for one day and subsequently discharged with oral medications. All 10 patients had subjective cosmetic improvement and improved prosthesis function. Furthermore, all patients felt that their orbital volume augmentation remained constant throughout the follow-up period. Postoperative photographs demonstrated improvement of the enophthalmos, including one case with over 3 years of follow-up (Figure 3).
Discussion Loss of the orbital volume following enucleation, evisceration, or phthisis bulbi creates a cosmetic and
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Figure 3. (a) and (b) External photographs of a patient with left enophthalmos following enucleation with a previously placed orbital implant. (c) and (d) Thirteen months after the original injection of 5 hydrogel pellets, and 3-week post-operative appearance following injection of 5 additional hydrogel pellets. (e) and (f) Three-year and 1-month follow-up from the original injection, and 2 years and one month follow-up from the second injection.
functional challenge. In contrast to more invasive surgical reconstruction options, a variety of alternative, less invasive orbital volume augmentation techniques have been attempted over the past 20 years.12 Crosslinked collagen, autologous fat, hyaluronic acid gel, hydroxylapatite, calcium triphosphate, silicone oil, fat pearls, and polyacrylamide gel have been injected into the orbital space.13–20 However, a short half-life, unpredictable volume restoration, inflammation, granuloma formation, scarring, migration, and allergic reactions limit the use of these substances. For example, softtissue fillers average a half-life of only 1 year when used for aesthetic facial purposes, and their long-term effect in orbital volume augmentation is yet to be determined.20 The ideal implant should be minimally invasive, volume-titratable, predictable, long-lasting, well-tolerated, and effective. In general, dynamic orbital implants are advantageous to static implants in that the volume of the implant enlarges to stimulate orbital growth even further. Besides hydrogel implants, other dynamic implants include dermis fat grafts and balloon expanders. Dermis fat grafts cause morbidity to the donor
site, and graft compatibility and growth can be variable. Fat can atrophy, or in rare cases hypertrophy, and during the time it takes for grafts to heal, there can be discharge, bleeding, or infection. Balloon expanders are associated with sudden high-pressure spikes, which can be painful to the patient and lead to erosions, extrusion, and atrophy of the surrounding tissue. In addition, balloon expanders require subfascial tracts or remote injection ports for further volume augmentation. In our experience, hydrogel implants offer many advantages of the ideal implant. Hydrogel spheres and pellets are relatively easy to place, with pellets injected in an office setting using local anesthesia alone. Their initial small size precludes the need for a large, central conjunctival incision, which is required for conventional spheres and dermis fat grafts, thereby decreasing operative and healing time, as well as reducing the chances for anterior wound breakdown and extrusion. In addition, the resultant volume can be predicted with the amount of local anesthetic injected into the orbit and titrated as needed based on the size of the spherical implant or the number of pellets placed. Moreover, hydrogel spheres expand on
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their own, slowly over time, avoiding the complications of subfascial tracts, remote injection ports, and sudden high-pressure spikes associated with balloon expanders. One limitation of our study is the average follow-up time period of 23.3 months, or median follow-up of 18.5 months, as many patients were lost to follow-up. One concern regarding the long-term use of hydrogel implants is whether they ever truly stop expanding. Hydrogel scleral buckles have been found to expand continually over time. Retinal buckling elements made of MIRAgel (MIRA, Waltham, MA) and its precursor, MAI, were popular products introduced in the late 1970s. Although effective in the short term, complications related to uncontrolled swelling of the material were recognized after 10+ years of use.21–24 There are now reports of buckle extrusions, fragmentation, intraocular erosion, migration, progressive limitation of motility, intraorbital fibrosis, mass effect, pain, foreign body granuloma formation, orbital cellulitis mimicry, forniceal shortening, and inflammatory orbital pseudotumor.21–30 In spite of these complications, the MIRAgel/MAI extrusion rate is significantly lower than for silicone buckling elements.21, 22 Moreover, the current hydrogel polymers are different from those used in MIRAgel/ MAI scleral buckles, with different base compounds, cross-linking, and polymerization characteristics, which make it more stable mechanically and appear to be tolerated differently from MIRAgel/MAI.8 The current hydrogel implants have been used successfully as orbital expanders in patients with congenital anophthalmia or microphthalmia since 1999, providing us with a longer experience.8,10,11 These studies showed no complications over a period of 1 to 2 years’ followup. Nevertheless, continued follow-up will be necessary to assess the long-term efficacy and safety of these hydrogel implants. In our experience with hydrogel implants, the two main complications were migration in two patients and significant postoperative pain in one patient after pellet injection. These were directly attributable to not placing the pellets posteriorly enough in the orbit and injecting too large a number of pellets in one sitting, respectively. Most patients experienced some discomfort in the first two to three days after implant placement when the material was undergoing initial expansion. In the vast majority of patients, this was successfully managed with oral analgesics, specifically oxycodone/paracetamol. Injecting 10 pellets during one session appears to exceed the maximum number of pellets that may be comfortably tolerated during the subsequent expansion phase. Both of these complications may be potentially avoided
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in the future by placing the pellets sufficiently posteriorly in the orbit at the time of the injection and by injecting fewer than 10 pellets per session. For all 14 patients, hydrogel implant placement resulted in overall improved orbital volume with good cosmetic and functional outcome over the study period, with no permanent complications. One recent study looks at hydrogel spheres implanted in cases of congenital microphthalmia.31 The authors describe five cases in which hydrogel spheres implanted via a lateral orbitotomy approach (similar to the one described here) ultimately migrated inferolaterally in the orbit, requiring surgical repositioning. This complication occurred fairly soon after their original implantation, from 3 weeks to 8 months in 4 of the cases, suggesting that migration may happen in children early on, during the most rapid period of implant expansion. This complication did not occur in our study during the follow-up period noted. There is no uniformly accepted strategy for rehabilitation of the anophthalmic socket with PESS or following phthisis. The importance of sufficient volume restoration at the time of the primary surgery cannot be overemphasized. In cases with inadequate volume replacement, hydrogel implants may provide an alternative means of treating acquired anophthalmia with associated orbital volume loss or phthisis. The primary limitation of this study is the limited follow-up time, and further studies will be necessary to assess the longer-term use of these implants.
Declaration of interest The authors report no conflicts of interest. The authors do not report any financial support. The authors alone are responsible for the content and writing of the article.
Funding Material support for this research (hydrogel implants) was partly provided by IOP, Inc. in Costa Mesa, CA. Presented in part at the American Academy of Ophthalmology Fall Scientific Symposium, November 2006, Las Vegas, NV. Also presented in part at the Association for Research in Vision and Ophthalmology, May 2014, Orlando, FL.
References 1. Tyers AG, Collin JR. Orbital implants and post enucleation socket syndrome. Trans Ophthalmol Soc UK 1982; 102 (Pt 1):90–92. 2. Das T, Namperumalsamy P. Scleral buckling with hydrogel implant. Ind J Ophthalmol 1991; 39(2):41–43. 3. Wheeler JC, Woods JA, Cox MJ, Cantrell RW, Watkins FH, Edlich RF. Evolution of hydrogel polymers as contact lenses, surface coatings, dressings, and drug
6
E. L. KIM ET AL.
4.
5.
6.
Downloaded by [Orta Dogu Teknik Universitesi] at 08:12 08 March 2016
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
delivery systems. J Long Term Eff Med Implants [Review]. 1996; 6(3-4):207–217. Wiese KG. Osmotically induced tissue expansion with hydrogels: a new dimension in tissue expansion? A preliminary report. J Craniomaxillofac Surg 1993; 21 (7):309–313. Wiese KG, Heinemann DE, Ostermeier D, Peters JH. Biomaterial properties and biocompatibility in cell culture of a novel self-inflating hydrogel tissue expander. J Biomed Mater Res 2001; 54(2):179–188. Bacskulin A, Vogel M, Wiese KG, Gundlach K, Hingst V, Guthoff R. New osmotically active hydrogel expander for enlargement of the contracted anophthalmic socket. Graefes Arch Clin Exp Ophthalmol [Comparative Study]. 2000; 238(1):24–27. Gundlach KK, Guthoff RF, Hingst VH, Schittkowski MP, Bier UC. Expansion of the socket and orbit for congenital clinical anophthalmia. Plast Reconstr Surg 2005; 116(5):1214–1222. Mazzoli RA, Raymond WRt, Ainbinder DJ, Hansen EA. Use of self-expanding, hydrophilic osmotic expanders (hydrogel) in the reconstruction of congenital clinical anophthalmos. Curr Opin Ophthalmol [Review] 2004; 15(5):426–431. Schittkowski MP, Gundlach KK, Guthoff RF. [Treatment of congenital clinical anophthalmos with high hydrophilic hydrogel expanders]. Ophthalmologe [Comparative Study]. 2003; 100(7):525–534. Schittkowski MP, Guthoff RF. Injectable self inflating hydrogel pellet expanders for the treatment of orbital volume deficiency in congenital microphthalmos: preliminary results with a new therapeutic approach. Br J Ophthalmol [Case Reports Evaluation Studies]. 2006; 90(9):1173–1177. Wiese KG, Vogel M, Guthoff R, Gundlach KK. Treatment of congenital anophthalmos with self-inflating polymer expanders: a new method. J Craniomaxillofac Surg 1999; 27(2):72–76. Tawfik HA, Raslan AO, Talib N. Surgical management of acquired socket contracture. Curr Opin Ophthalmol [Review]. 2009; 20(5):406–411. Adenis JP, Bertin P, Lasudry JG, Boncoeur-Martel MP, Leboutet MJ, Robert PY. Treatment of the postenucleation socket syndrome with a new hydroxyapatite tricalcium phosphate ceramic implant. Ophthal Plast Reconstr Surg 1999; 15(4):277–283. Cahill KV, Burns JA. Volume augmentation of the anophthalmic orbit with cross-linked collagen (Zyplast). Arch Ophthalmol [Case Reports] 1989; 107 (11):1684–1686. da Silva AL, Bredemeier M, Gebrim ES, Moura Eda M. Intraorbital polyacrylamide gel injection for the treatment of anophthalmic enophthalmos. Ophthal Plast Reconstr Surg [Clinical Trial Research Support, NonU.S. Gov’t]. 2008; 24(5):367–371. Hunter PD, Baker SS. The treatment of enophthalmos by orbital injection of fat autograft. Arch Otolaryngol Head Neck Surg 1994; 120(8):835–839.
17. Kotlus BS, Dryden RM. Correction of anophthalmic enophthalmos with injectable calcium hydroxylapatite (Radiesse). Ophthal Plast Reconstr Surg [Case Reports]. 2007 Jul-Aug;23(4):313–314. 18. Laiseca A, Laiseca D, Laiseca J, Laiseca J, Jr. Correcting superior sulcus deformities. Adv Ophthalmic Plast Reconstr Surg [Review] 1990; 8:229–242. 19. Malhotra R. Deep orbital Sub-Q restylane (nonanimal stabilized hyaluronic acid) for orbital volume enhancement in sighted and anophthalmic orbits. Arch Ophthalmol [Case Reports] 2007; 125(12):1623–1629. 20. Vagefi MR, McMullan TF, Burroughs JR, Georgescu D, McCann JD, Anderson RL. Orbital augmentation with injectable calcium hydroxylapatite for correction of postenucleation/evisceration socket syndrome. Ophthal Plast Reconstr Surg 2011; 27(2):90–94. 21. Brown SL, Bloom SM. Spontaneous expulsion of a radial miragel scleral buckle. Retina [Case Reports] 2004; 24(2):306–307. 22. Le Rouic JF, Bettembourg O, D’Hermies F, Azan F, Renard G, Chauvaud D. Late swelling and removal of Miragel buckles: a comparison with silicone indentations. Retina [Comparative Study] 2003; 23(5):641– 646. 23. Kearney JJ, Lahey JM, Borirakchanyavat S, Schwartz DM, Wilson D, Tanaka SC, et al. Complications of hydrogel explants used in scleral buckling surgery. Am J Ophthalmol 2004; 137(1):96–100. 24. Braunstein RA, Winnick M. Photo essay: complications of Miragel: pseudotumor. Arch Ophthalmol [Case Reports] 2002; 120(2):228–229. 25. Kawano T, Doi M, Miyamura M, Esaki K, Sasoh M, Uji Y. Extrusion and fragmentation of hydrogel exoplant 11 years after scleral buckling surgery. Ophthalmic Surg Lasers [Case Reports] 2002; 33(3):240–242. 26. Roldan-Pallares M, del Castillo Sanz JL, Awad-El Susi S, Refojo MF. Long-term complications of silicone and hydrogel explants in retinal reattachment surgery. Arch Ophthalmol 1999; 117(2):197–201. 27. Hwang KI, Lim JI. Hydrogel exoplant fragmentation 10 years after scleral buckling surgery. Arch Ophthalmol [Case Reports Letter]. 1997; 115(9):1205–1206. 28. Marin JF, Tolentino FI, Refojo MF, Schepens CL. Long-term complications of the MAI hydrogel intrascleral buckling implant. Arch Ophthalmol [Case Reports Research Support, Non-U.S. Gov’t Research Support, U.S. Gov’t, P.H.S.]. 1992; 110(1):86–88. 29. Li K, Lim KS, Wong D. Miragel explant fragmentation 10 years after scleral buckling surgery. Eye (Lond) [Case Reports Letter Review]. 2003; 17(2):248–250. 30. Bernardino CR, Mihora LD, Fay AM, Rubin PA. Orbital complications of hydrogel scleral buckles. Ophthal Plast Reconstr Surg [Case Reports Research Support, Non-U.S. Gov’t]. 2006; 22(3):206–208. 31. Tao JP, LeBoyer RM, Hetzler K, Ng JD, Nunery WR. Inferolateral migration of hydrogel orbital implants in microphthalmia. Ophthal Plast Reconstr Surg [Case Reports] 2010; 26(1):14–17.
ISSN: 0167-6830 (Print) 1744-5108 (Online) Journal homepage: http://www.tandfonline.com/loi/iorb20
Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi Esther Lee Kim, Carlo Rob Bernardino & Flora Levin To cite this article: Esther Lee Kim, Carlo Rob Bernardino & Flora Levin (2016): Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi, Orbit, DOI: 10.3109/01676830.2016.1139593 To link to this article: http://dx.doi.org/10.3109/01676830.2016.1139593
Published online: 29 Feb 2016.
Submit your article to this journal
Article views: 8
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=iorb20 Download by: [Orta Dogu Teknik Universitesi]
Date: 08 March 2016, At: 08:12
ORBIT 2016, VOL. 0, NO. 0, 1–6 http://dx.doi.org/10.3109/01676830.2016.1139593
CLINICAL RESEARCH
Orbital volume augmentation using expandable hydrogel implants in acquired anophthalmia and phthisis bulbi Esther Lee Kima,b, Carlo Rob Bernardino,c and Flora Levinb
Downloaded by [Orta Dogu Teknik Universitesi] at 08:12 08 March 2016
a Department of Ophthalmology, University of Southern California Eye Institute, Los Angeles, California, USA; bDepartment of Ophthalmology & Visual Science, Yale Eye Center, New Haven, Connecticut, USA; cOculoplastics and Aesthetic Surgery, Vantage Eye Center, Monterey, California, USA
ABSTRACT
ARTICLE HISTORY
The purpose of this study is to describe our experience using expandable spherical hydrogel implants and injectable hydrogel pellets for orbital volume augmentation in cases of postenucleation socket syndrome after acquired anophthalmia or phthisis bulbi. We retrospectively reviewed the clinical records of all adult patients who received an expandable hydrogel implant for orbital volume loss following enucleation or phthisis bulbi at the Emory Eye Center between 2004 and January 2007 and the Yale Eye Center between 2009 and 2011. The study included 9 women and 5 men with a mean age of 51.2 years old (range 35-76 years old). Follow-up spanned 6 to 71 months (median of 18.5 months). Four patients received spherical hydrogel implants and 10 patients received hydrogel pellet injections. On average, nine pellets (range 5-16) were placed in each patient over an average of 1.7 injections (range 1-3). Most commonly, five pellets were injected per session, as was the case for 13 of the 17 treatment sessions. Post-operative complications included 2 cases of pellet migration, one subcutaneously and one anteriorly due to insufficiently posterior implant placement, and 1 hospital admission for pain after injection of 10 pellets in one visit. All patients experienced an overall subjective improvement in cosmesis. Self-expandable hydrogel implants appear to offer several advantages over other existing options for orbital volume augmentation, as they are easy to place, generally well-tolerated, volumetitratable, and to the extent that our follow-up shows, may be a safe and durable means of treating orbital volume loss in patients with acquired anophthalmia and phthisis bulbi.
Received 23 November 2014 Accepted 4 January 2016
Introduction Insufficient orbital volume following enucleation or evisceration can result in post-enucleation socket syndrome (PESS), characterized by enophthalmos, a deep superior sulcus, ptosis or eyelid retraction, lower eyelid laxity, and poor prosthesis functioning.1 Longstanding phthisis can result in orbital volume deficiency similar to PESS. Patients with PESS fit into one of two categories: those without an orbital implant or those with an inadequately sized orbital implant and/or with surrounding volume loss. Patients in the former category can achieve volume augmentation with a secondary spherical orbital implant or a dermis fat graft. Those in the latter category may undergo implant exchange, enophthalmic wedge placement, soft-tissue fillers, or autologous tissue implants including fat grafts. In patients with phthisis, a thick scleral shell can be worn over the phthisical eye, or if not tolerated due to size or fit, an enucleation or
KEYWORDS
Anophthalmia; hydrogel; implants; phthisis bulb
evisceration can be performed with placement of appropriate implant. There continues to be little consensus regarding the choice of orbital implant material and design. Many of the existing volume augmentation techniques have significant drawbacks, as they may be costly, temporary, or lengthy procedures carrying additional risks, such as donor site morbidity. The ideal implant would be one that is easy to place, biocompatible, volume-titratable, predictable, long-lasting, non-toxic, and cost-effective. Hydrogel (copolymer of methylmethacrylate and N-vinylpyrrolidone) is a highly hydrophilic, selfexpanding material previously used in soft contact lenses and scleral buckles,2,3 Dehydrated, the material is small and solid, thereby allowing easy insertion into the socket. Hydrated, the implants swell to become a pliable, gelatin-like material up to 12 times the original volume.4,5 Hydrogel implants are available in three shapes for different purposes: spheres, hemispheres
CONTACT Esther Lee Kim [email protected] Department of Ophthalmology, University of Southern California Eye Institute, 1450 San Pablo St, Suite 4900, Los Angeles, California 90033, USA. Color versions for one or more of the figures in the article can be found online at www.tandfonline.com/iorb. © 2016 Taylor & Francis
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and pellets. A sphere may be used for bony orbital expansion in congenital cases or as a secondary implant for volume augmentation and improved prosthesis fitting and function. A hemisphere may be used for socket and palpebral fissure expansion, while pellets allow for orbital volume augmentation in the case of an existing implant or globe. The implants exert a constant hydrostatic pressure of 20–30 mmHg as they swell. According to the manufacturer, the bony orbital expansion may take six months for full effect. Hydrogel implants have been used successfully for congenital anophthalmia and microphthalmia, with an average follow-up period of 9.7 months.6–11 However, to the best of our knowledge, their use has not been reported following acquired anophthalmia or phthisis bulbi. In this study, we present our initial experience using the sphere and pellet hydrogel implants in 14 patients with orbital volume loss from acquired anophthalmia or phthisis. Furthermore, we provide a longer follow-up period than previously reported, with an average of 15.8 months’ follow-up for spheres and 26.3 months for pellet injections.
photographs were analyzed. All study procedures were compliant with the Health Insurance Portability and Accountability Act and the Declaration of Helsinski for research involving human participants.
Surgical technique: Spherical implant Spherical hydrogel implants (Figure 1a) are available in four final volumes—2.0, 3.0, 4.0, and 5.0 ml. Placement of spherical hydrogel implants is performed in the operating room under intravenous sedation with a retrobulbar block or general anesthesia. After a lid speculum is placed, a small, 1-cm lateral canthal incision is made, and the lateral orbital rim periosteum is bluntly dissected deep into the orbit. After visualizing the intraconal space, the rectus muscles and/or the optic nerve are palpated to confirm location. A dehydrated hydrogel sphere is then pushed into the deep orbit. An anterior transconjunctival approach can also be used in lieu of the lateral orbitotomy approach. Tenons is closed with 5-0 polyglactin suture in a buried fashion, and the conjunctiva with 6-0 fast-absorbing gut suture. A conformer is then placed in the conjunctival socket.
Material and methods We retrospectively reviewed the clinical records of all patients who received an expandable hydrogel orbital implant (Osmed hydrogel tissue expanders, IOP Inc., Costa Mesa, CA) for orbital volume loss following enucleation or phthisis bulbi at Emory Clinic between 2003 and January 2007 and the Yale Eye Center between 2009 and 2011. Three patients with incomplete data were excluded from the study. The data collected included gender, age at the time of implantation, previous ophthalmic conditions, type of hydrogel implant, number of pellets and injections required, follow-up time, and complications. Outcome measures were postoperative appearance, prosthesis function, and procedurerelated complications. Preoperative and postoperative
Surgical technique: Pellet implant Pellet hydrogel implants (Figure 1b) are 0.2 ml each in final volume. Unlike the spherical hydrogel implants, which require placement in the operating room, hydrogel pellets can be placed under local anesthesia in an office setting. Lidocaine 2% with epinephrine 1:100,000 was instilled as a retrobulbar block. The final result was anticipated by the volume augmentation effect produced by the amount of local anesthetic solution injected in the orbital apex region. The included trocar is inserted transcutaneously along the orbital floor and directed posterior to the orbital implant or phthisical globe (Figures 2a and 2b). The pellets are placed deep
Figure 1. Hydrogel implants pre- and post-hydration. (a) Sphere, (b) pellet.
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No orbital implant Four patients received a secondary spherical hydrogel implant. One patient required a 3.0-ml implant, two patients required 4.0-ml implants, and one patient required a 5.0-ml implant. The follow-up period ranged from 8 to 30 months, with an average follow-up time of 15.8 months. In all 4 cases, there were no infections or extrusions over the follow-up periods. All patients had subjective cosmetic improvement and were successfully fit with prostheses.
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Figure 2. Hydrogel pellet injection. (a) and (b) Trocar is introduced transcutaneously just above the orbital rim. (c) Hydrogel pellets are placed via the cannula.
into the socket (Figure 2c), and the volume is adjusted by the number of implants placed.
Results Fourteen patients received hydrogel implants, including 9 females and 5 males. Average age at the time of implantation was 51.2 years old, with ages ranging from 35 to 76 years old. Four patients received spherical hydrogel implants, and 10 patients underwent hydrogel pellet injections.
Ten patients were treated with injectable hydrogel pellets for enophthalmos. Eight patients had acquired anophthalmia with prior placement of a primary orbital implant and two patients had a phthisical globe. An average of 9 pellets (range 5–16) were placed in each patient over an average of 1.7 injections (range 1–3). Most commonly, five pellets were injected per session, as was the case for 13 of the 17 total treatment sessions. The most number of pellets placed in one sitting was 10 in one patient. The follow-up period ranged from 6 to 71 months, with an average follow-up time period of 26.3 months. There were no signs of infection, rejection, extrusion, or inflammation attributable to the pellets during the follow-up period. There were two cases of pellet migration, both due to insufficiently posterior placement of the implants into the deep orbit. One patient required removal of one pellet that migrated subcutaneously. Another patient with five implants placed initially had anterior migration of several pellets two weeks following insertion, requiring removal of 4 pellets. This patient had 5 additional pellets inserted less than 4 months later with a good final outcome. The one patient who had 10 pellets placed in one setting had postoperative pain and vomiting, which required hospitalization. The patient was hospitalized for one day and subsequently discharged with oral medications. All 10 patients had subjective cosmetic improvement and improved prosthesis function. Furthermore, all patients felt that their orbital volume augmentation remained constant throughout the follow-up period. Postoperative photographs demonstrated improvement of the enophthalmos, including one case with over 3 years of follow-up (Figure 3).
Discussion Loss of the orbital volume following enucleation, evisceration, or phthisis bulbi creates a cosmetic and
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Figure 3. (a) and (b) External photographs of a patient with left enophthalmos following enucleation with a previously placed orbital implant. (c) and (d) Thirteen months after the original injection of 5 hydrogel pellets, and 3-week post-operative appearance following injection of 5 additional hydrogel pellets. (e) and (f) Three-year and 1-month follow-up from the original injection, and 2 years and one month follow-up from the second injection.
functional challenge. In contrast to more invasive surgical reconstruction options, a variety of alternative, less invasive orbital volume augmentation techniques have been attempted over the past 20 years.12 Crosslinked collagen, autologous fat, hyaluronic acid gel, hydroxylapatite, calcium triphosphate, silicone oil, fat pearls, and polyacrylamide gel have been injected into the orbital space.13–20 However, a short half-life, unpredictable volume restoration, inflammation, granuloma formation, scarring, migration, and allergic reactions limit the use of these substances. For example, softtissue fillers average a half-life of only 1 year when used for aesthetic facial purposes, and their long-term effect in orbital volume augmentation is yet to be determined.20 The ideal implant should be minimally invasive, volume-titratable, predictable, long-lasting, well-tolerated, and effective. In general, dynamic orbital implants are advantageous to static implants in that the volume of the implant enlarges to stimulate orbital growth even further. Besides hydrogel implants, other dynamic implants include dermis fat grafts and balloon expanders. Dermis fat grafts cause morbidity to the donor
site, and graft compatibility and growth can be variable. Fat can atrophy, or in rare cases hypertrophy, and during the time it takes for grafts to heal, there can be discharge, bleeding, or infection. Balloon expanders are associated with sudden high-pressure spikes, which can be painful to the patient and lead to erosions, extrusion, and atrophy of the surrounding tissue. In addition, balloon expanders require subfascial tracts or remote injection ports for further volume augmentation. In our experience, hydrogel implants offer many advantages of the ideal implant. Hydrogel spheres and pellets are relatively easy to place, with pellets injected in an office setting using local anesthesia alone. Their initial small size precludes the need for a large, central conjunctival incision, which is required for conventional spheres and dermis fat grafts, thereby decreasing operative and healing time, as well as reducing the chances for anterior wound breakdown and extrusion. In addition, the resultant volume can be predicted with the amount of local anesthetic injected into the orbit and titrated as needed based on the size of the spherical implant or the number of pellets placed. Moreover, hydrogel spheres expand on
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their own, slowly over time, avoiding the complications of subfascial tracts, remote injection ports, and sudden high-pressure spikes associated with balloon expanders. One limitation of our study is the average follow-up time period of 23.3 months, or median follow-up of 18.5 months, as many patients were lost to follow-up. One concern regarding the long-term use of hydrogel implants is whether they ever truly stop expanding. Hydrogel scleral buckles have been found to expand continually over time. Retinal buckling elements made of MIRAgel (MIRA, Waltham, MA) and its precursor, MAI, were popular products introduced in the late 1970s. Although effective in the short term, complications related to uncontrolled swelling of the material were recognized after 10+ years of use.21–24 There are now reports of buckle extrusions, fragmentation, intraocular erosion, migration, progressive limitation of motility, intraorbital fibrosis, mass effect, pain, foreign body granuloma formation, orbital cellulitis mimicry, forniceal shortening, and inflammatory orbital pseudotumor.21–30 In spite of these complications, the MIRAgel/MAI extrusion rate is significantly lower than for silicone buckling elements.21, 22 Moreover, the current hydrogel polymers are different from those used in MIRAgel/ MAI scleral buckles, with different base compounds, cross-linking, and polymerization characteristics, which make it more stable mechanically and appear to be tolerated differently from MIRAgel/MAI.8 The current hydrogel implants have been used successfully as orbital expanders in patients with congenital anophthalmia or microphthalmia since 1999, providing us with a longer experience.8,10,11 These studies showed no complications over a period of 1 to 2 years’ followup. Nevertheless, continued follow-up will be necessary to assess the long-term efficacy and safety of these hydrogel implants. In our experience with hydrogel implants, the two main complications were migration in two patients and significant postoperative pain in one patient after pellet injection. These were directly attributable to not placing the pellets posteriorly enough in the orbit and injecting too large a number of pellets in one sitting, respectively. Most patients experienced some discomfort in the first two to three days after implant placement when the material was undergoing initial expansion. In the vast majority of patients, this was successfully managed with oral analgesics, specifically oxycodone/paracetamol. Injecting 10 pellets during one session appears to exceed the maximum number of pellets that may be comfortably tolerated during the subsequent expansion phase. Both of these complications may be potentially avoided
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in the future by placing the pellets sufficiently posteriorly in the orbit at the time of the injection and by injecting fewer than 10 pellets per session. For all 14 patients, hydrogel implant placement resulted in overall improved orbital volume with good cosmetic and functional outcome over the study period, with no permanent complications. One recent study looks at hydrogel spheres implanted in cases of congenital microphthalmia.31 The authors describe five cases in which hydrogel spheres implanted via a lateral orbitotomy approach (similar to the one described here) ultimately migrated inferolaterally in the orbit, requiring surgical repositioning. This complication occurred fairly soon after their original implantation, from 3 weeks to 8 months in 4 of the cases, suggesting that migration may happen in children early on, during the most rapid period of implant expansion. This complication did not occur in our study during the follow-up period noted. There is no uniformly accepted strategy for rehabilitation of the anophthalmic socket with PESS or following phthisis. The importance of sufficient volume restoration at the time of the primary surgery cannot be overemphasized. In cases with inadequate volume replacement, hydrogel implants may provide an alternative means of treating acquired anophthalmia with associated orbital volume loss or phthisis. The primary limitation of this study is the limited follow-up time, and further studies will be necessary to assess the longer-term use of these implants.
Declaration of interest The authors report no conflicts of interest. The authors do not report any financial support. The authors alone are responsible for the content and writing of the article.
Funding Material support for this research (hydrogel implants) was partly provided by IOP, Inc. in Costa Mesa, CA. Presented in part at the American Academy of Ophthalmology Fall Scientific Symposium, November 2006, Las Vegas, NV. Also presented in part at the Association for Research in Vision and Ophthalmology, May 2014, Orlando, FL.
References 1. Tyers AG, Collin JR. Orbital implants and post enucleation socket syndrome. Trans Ophthalmol Soc UK 1982; 102 (Pt 1):90–92. 2. Das T, Namperumalsamy P. Scleral buckling with hydrogel implant. Ind J Ophthalmol 1991; 39(2):41–43. 3. Wheeler JC, Woods JA, Cox MJ, Cantrell RW, Watkins FH, Edlich RF. Evolution of hydrogel polymers as contact lenses, surface coatings, dressings, and drug
6
E. L. KIM ET AL.
4.
5.
6.
Downloaded by [Orta Dogu Teknik Universitesi] at 08:12 08 March 2016
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
delivery systems. J Long Term Eff Med Implants [Review]. 1996; 6(3-4):207–217. Wiese KG. Osmotically induced tissue expansion with hydrogels: a new dimension in tissue expansion? A preliminary report. J Craniomaxillofac Surg 1993; 21 (7):309–313. Wiese KG, Heinemann DE, Ostermeier D, Peters JH. Biomaterial properties and biocompatibility in cell culture of a novel self-inflating hydrogel tissue expander. J Biomed Mater Res 2001; 54(2):179–188. Bacskulin A, Vogel M, Wiese KG, Gundlach K, Hingst V, Guthoff R. New osmotically active hydrogel expander for enlargement of the contracted anophthalmic socket. Graefes Arch Clin Exp Ophthalmol [Comparative Study]. 2000; 238(1):24–27. Gundlach KK, Guthoff RF, Hingst VH, Schittkowski MP, Bier UC. Expansion of the socket and orbit for congenital clinical anophthalmia. Plast Reconstr Surg 2005; 116(5):1214–1222. Mazzoli RA, Raymond WRt, Ainbinder DJ, Hansen EA. Use of self-expanding, hydrophilic osmotic expanders (hydrogel) in the reconstruction of congenital clinical anophthalmos. Curr Opin Ophthalmol [Review] 2004; 15(5):426–431. Schittkowski MP, Gundlach KK, Guthoff RF. [Treatment of congenital clinical anophthalmos with high hydrophilic hydrogel expanders]. Ophthalmologe [Comparative Study]. 2003; 100(7):525–534. Schittkowski MP, Guthoff RF. Injectable self inflating hydrogel pellet expanders for the treatment of orbital volume deficiency in congenital microphthalmos: preliminary results with a new therapeutic approach. Br J Ophthalmol [Case Reports Evaluation Studies]. 2006; 90(9):1173–1177. Wiese KG, Vogel M, Guthoff R, Gundlach KK. Treatment of congenital anophthalmos with self-inflating polymer expanders: a new method. J Craniomaxillofac Surg 1999; 27(2):72–76. Tawfik HA, Raslan AO, Talib N. Surgical management of acquired socket contracture. Curr Opin Ophthalmol [Review]. 2009; 20(5):406–411. Adenis JP, Bertin P, Lasudry JG, Boncoeur-Martel MP, Leboutet MJ, Robert PY. Treatment of the postenucleation socket syndrome with a new hydroxyapatite tricalcium phosphate ceramic implant. Ophthal Plast Reconstr Surg 1999; 15(4):277–283. Cahill KV, Burns JA. Volume augmentation of the anophthalmic orbit with cross-linked collagen (Zyplast). Arch Ophthalmol [Case Reports] 1989; 107 (11):1684–1686. da Silva AL, Bredemeier M, Gebrim ES, Moura Eda M. Intraorbital polyacrylamide gel injection for the treatment of anophthalmic enophthalmos. Ophthal Plast Reconstr Surg [Clinical Trial Research Support, NonU.S. Gov’t]. 2008; 24(5):367–371. Hunter PD, Baker SS. The treatment of enophthalmos by orbital injection of fat autograft. Arch Otolaryngol Head Neck Surg 1994; 120(8):835–839.
17. Kotlus BS, Dryden RM. Correction of anophthalmic enophthalmos with injectable calcium hydroxylapatite (Radiesse). Ophthal Plast Reconstr Surg [Case Reports]. 2007 Jul-Aug;23(4):313–314. 18. Laiseca A, Laiseca D, Laiseca J, Laiseca J, Jr. Correcting superior sulcus deformities. Adv Ophthalmic Plast Reconstr Surg [Review] 1990; 8:229–242. 19. Malhotra R. Deep orbital Sub-Q restylane (nonanimal stabilized hyaluronic acid) for orbital volume enhancement in sighted and anophthalmic orbits. Arch Ophthalmol [Case Reports] 2007; 125(12):1623–1629. 20. Vagefi MR, McMullan TF, Burroughs JR, Georgescu D, McCann JD, Anderson RL. Orbital augmentation with injectable calcium hydroxylapatite for correction of postenucleation/evisceration socket syndrome. Ophthal Plast Reconstr Surg 2011; 27(2):90–94. 21. Brown SL, Bloom SM. Spontaneous expulsion of a radial miragel scleral buckle. Retina [Case Reports] 2004; 24(2):306–307. 22. Le Rouic JF, Bettembourg O, D’Hermies F, Azan F, Renard G, Chauvaud D. Late swelling and removal of Miragel buckles: a comparison with silicone indentations. Retina [Comparative Study] 2003; 23(5):641– 646. 23. Kearney JJ, Lahey JM, Borirakchanyavat S, Schwartz DM, Wilson D, Tanaka SC, et al. Complications of hydrogel explants used in scleral buckling surgery. Am J Ophthalmol 2004; 137(1):96–100. 24. Braunstein RA, Winnick M. Photo essay: complications of Miragel: pseudotumor. Arch Ophthalmol [Case Reports] 2002; 120(2):228–229. 25. Kawano T, Doi M, Miyamura M, Esaki K, Sasoh M, Uji Y. Extrusion and fragmentation of hydrogel exoplant 11 years after scleral buckling surgery. Ophthalmic Surg Lasers [Case Reports] 2002; 33(3):240–242. 26. Roldan-Pallares M, del Castillo Sanz JL, Awad-El Susi S, Refojo MF. Long-term complications of silicone and hydrogel explants in retinal reattachment surgery. Arch Ophthalmol 1999; 117(2):197–201. 27. Hwang KI, Lim JI. Hydrogel exoplant fragmentation 10 years after scleral buckling surgery. Arch Ophthalmol [Case Reports Letter]. 1997; 115(9):1205–1206. 28. Marin JF, Tolentino FI, Refojo MF, Schepens CL. Long-term complications of the MAI hydrogel intrascleral buckling implant. Arch Ophthalmol [Case Reports Research Support, Non-U.S. Gov’t Research Support, U.S. Gov’t, P.H.S.]. 1992; 110(1):86–88. 29. Li K, Lim KS, Wong D. Miragel explant fragmentation 10 years after scleral buckling surgery. Eye (Lond) [Case Reports Letter Review]. 2003; 17(2):248–250. 30. Bernardino CR, Mihora LD, Fay AM, Rubin PA. Orbital complications of hydrogel scleral buckles. Ophthal Plast Reconstr Surg [Case Reports Research Support, Non-U.S. Gov’t]. 2006; 22(3):206–208. 31. Tao JP, LeBoyer RM, Hetzler K, Ng JD, Nunery WR. Inferolateral migration of hydrogel orbital implants in microphthalmia. Ophthal Plast Reconstr Surg [Case Reports] 2010; 26(1):14–17.
