ONE-YEAR OUTCOMES OF EYES TREATED WITH A SUTURELESS SCLERAL FIXATION TECHNIQUE FOR INTRAOCULAR LENS PLACEMENT OR RESCUE JOHN D. WILGUCKI, BS,* H. MATTHEW WHEATLEY, MD,*† LEONARD FEINER, MD, PHD,* MARK V. FERRONE, JONATHAN L. PRENNER, MD*† Purpose: To report the 1 year results of a novel surgical technique for sutureless scleral fixation of a 3-piece intraocular lens. Methods: Retrospective consecutive series of patients who underwent sutureless scleral fixation of a three-piece intraocular lens. All patients were required to have at least 1 year of follow-up to be included in the series. Outcomes data were obtained and treated with simple statistical analyses. Results: A total of 24 patients were included in the study population. The average age was 75 years (range, 44–87). Short-term complications were few and included vitreous hemorrhage (n = 2), elevated intraocular pressure (n = 1), and hypotony (n = 1). Longterm complications included intraocular lens dislocation (n = 3) and cystoid macular edema (n = 1). Mean visual acuity improved from logMAR 1.30 (Snellen 20/399) to 0.52 (Snellen 20/66) at 1 year. Conclusion: This novel technique for sutureless scleral fixation of a three-piece intraocular lens was well-tolerated 1 year after surgery. RETINA 35:1036–1040, 2015
E
yes that lack sufficient capsular support for intraocular lens (IOL) placement present a unique surgical challenge when IOL implantation or rescue is required. Standard surgical approaches include placement of an anterior chamber IOL (ACIOL) or suture fixation of a posterior chamber IOL (PCIOL) to the iris or sclera. In addition, we have previously reported short-term results of our novel approach to sutureless scleral fixation (SSF) of a three-piece IOL.1 The American Academy of Ophthalmology Ophthalmic Technology Assessment reviewed the standard approaches and found them to be essentially equivalent in terms of eventual visual outcome.2 These well-tested
techniques also have well-documented complications, including the development of glaucoma, intraocular inflammation, corneal decompensation, and suture degradation with IOL dislocation.3–12 In an attempt to avoid the complications of the previously described approaches, we developed a technique that allows for ciliary sulcus-based scleral fixation of a PCIOL without the use of sutures, scleral flaps, or fibrin glue.1 This approach is intended to avoid the anterior chamber complications of ACIOL placement and the risk of IOL malposition secondary to suture failure over time. We significantly modified an anterior segment technique that takes advantage of the surgical instrumentation and the skill set of the posterior segment surgeon.13 These modifications allow for a reproducible and reliable surgical procedure that can be used for both the rescue of a dislocated IOL and for the implantation of a secondary IOL. Sutureless scleral fixation allows for permanent scleral fixation of the polymethylmethacrylate haptics of
From the *Department of Ophthalmology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey; and †Department of Ophthalmology, NJ Retina, New Brunswick, New Jersey. None of the authors have any financial/conflicting interests to disclose. Reprint requests: Jonathan L. Prenner, MD, 10 Plum Street, Suite 600, New Brunswick, NJ 08901; e-mail: jonathanprenner@ gmail.com
1036
SUTURELESS IOL FIXATION 1-YEAR OUTCOMES WILGUCKI ET AL
a three-piece IOL directly into the sclera, eliminating the need for suturing and achieving a position in the ciliary sulcus. Here, we report the 1-year follow-up of 24 eyes that underwent the SSF procedure in an attempt to further evaluate the efficacy and safety of the previously described procedure. Patients and Methods We conducted a retrospective chart review of a consecutive series of 24 eyes of 24 patients who underwent PCIOL implantation or rescue using the SSF technique. Three surgeons (J.L.P., H.M.W., L.F.) performed the identical procedure over a 2-year interval (December 2009 to June 2011). All patients were followed for at least 1 year. Institutional review board approval was obtained before the initiation of this study. Preoperative data captured included visual acuity, intraocular pressure, indication for surgery and the presence of additional ocular comorbidities. Postoperative data collected at Months 3 and 12 included visual acuity, intraocular pressure, IOL position, and the presence of any additional complications. Surgical Technique Here, we briefly describe the surgical technique and have previously demonstrated our surgical procedure in the supplemental digital content from our initial publication.1 A conjunctival peritomy is performed on the temporal 270°, and light scleral cautery is used to achieve adequate hemostasis. After a standard 23-gauge (g) 3-port vitrectomy is performed, 2 ciliary sulcus-based sclerotomies (CSS) are created with a 20-g microvitreoretinal blade. These sclerotomies are made in a parallel orientation, 2 mm from the limbus to achieve a ciliary sulcus location, and are positioned exactly 180° apart at the 6-o’clock and 12-o’ clock positions. This precise positioning is required to assure appropriate lens centration. Then, the blade from the 23-g trochar system is used to create a 3-mm long partial thickness scleral tunnel to connect with each CSS. These tunnels are created parallel to the limbus and must be made in a uniplanar manner. Passing the blade from the temporal to the nasal position helps to avoid challenging hand positions that make creating uniplanar parallel tunnels more difficult. For example, in a left eye, the superior scleral tunnel is started in the opening of the 12-o’clock CSS and passed nasally until blade exits the sclera 3 mm from the CSS. The inferior tunnel is started 3 mm temporally from the 6-o’clock CSS and extended nasally exiting the sclera
1037
in the base of the CSS. The haptics are oriented in the confuration of a backwards S (surgeons view) to confirm that IOL has the proper orientation and tilt as designed. After the tunnels have been created, attention is paid to IOL placement. A disposable 25-g internal limiting membrane forceps is bent 45° to 60° in the middle of the shaft. Actuation of the forceps works well even with this degree of distortion. In aphakic eyes, a 4-mm clear corneal incision is made with a keratome; viscoelastic is injected into the anterior chamber to protect the corneal endothelium. After injection of a 3-piece PCIOL (we typically use the Alcon MA-60AC; Alcon Laboratories Inc, Fort Worth, TX) into the anterior chamber, the bent 25-g forceps is passed through the inferior CSS, and the leading haptic is grasped. The haptic does not need to be engaged at the tip but rather can be engaged anywhere along the distal half of the haptic and is then externalized. It is possible to pull the haptic too forcefully and disengage it from the optic although this is not a common problem. The IOL can then be drawn into the sulcus through the externalized leading haptic. The superior (trailing) haptic is then grasped with the bent 25-g forceps through the superior CSS and externalized in a similar fashion. Because of the 20-g width of the CSS, the haptics bend but will not break during externalization even when not grasped at the tip of the haptic. In cases of a dislocated PCIOL, the IOL is initially freed from any residual capsule using one or two forceps and the vitreous cutter. The discarded capsule is removed with the cutter, and the lens is elevated with a forceps to a position just posterior to the iris plane. The bent 25-g forceps is next passed through the inferior CSS and used to grasp the inferior haptic and externalize it. A similar process is performed to externalize the superior haptic. The scleral tunnels are recanalized with the 25-g forceps because the sclera surrounding the tunnels rehydrates and reestablishing the caliber of the tunnel facilitates haptic implantation. Haptic placement into the tunnel is performed in a temporal-to-nasal direction to assure the most advantageous hand positions and angles. If we again assume that the surgical eye is the left eye, the 25-g forceps is passed through from the distal end of the inferior tunnel into the CSS, first exposing the tip of the forceps through the CSS. The tip of the haptic is then handed from a smooth tying forceps into the open mouth of the 25-g forceps. Once the haptic is engaged, the 25-g forceps is drawn out of the tunnel. The tip of the haptic should be drawn far enough so that it passes through the distal end of the tunnel. For implantation superiorly, the haptic is
1038 RETINA, THE JOURNAL OF RETINAL AND VITREOUS DISEASES
grasped at the tip and is pushed through the tunnel with counter traction applied by a 0.12 mm forceps. The haptic tip should be pushed so that it exits the distal end of the tunnel and is then secured with a tying forceps while the 25-g forceps is removed. Final centration is achieved by manipulation of the haptic tips and the tips are cut flush to the sclera with a scissor. We recommend suturing the CSS with 7-0 Vicryl suture and the 23-g trochar blade wounds and clear corneal incision, if leaking. The conjunctiva can then be closed.
Results A total of 24 patients (15 male, 9 female) met entry criteria and were included in the study cohort. The average age of the study population was 75 years (range, 44–87 years). The indications for surgery in the study cohort are detailed in Table 1. Eighteen eyes (75%) required surgery for lens dislocation, with the other 6 eyes (25%) requiring surgery for other reasons, including aphakia and corneal decompensation. There were a total of 7 patients who underwent SSF between December 2009 and July 2011 who were excluded from the study because they did not fulfill the 1-year follow-up requirement set by the authors. Each one of these patients was individually contacted in attempt to reconnect for follow-up. Five patients refused to comply for a follow-up appointment, one patient moved out of state unable to return to the office and one patient was deceased. Table 2 illustrates the short-term complications experienced by the study cohort. These short-term complications were defined as occurring within 1 month of surgery. Two eyes developed vitreous hemorrhage (8%). One of these eyes was treated with additional vitrectomy, whereas the other resolved spontaneously by the 1-month follow-up examination. One patient who developed elevated intraocular pressure was treated with Combigan that was stopped 3 weeks later after the discontinuation of topical
2015 VOLUME 35 NUMBER 5
Table 2. Short-term Postoperative Complications Complication Vitreous hemorrhage Conjunctival hemorrhage Elevated IOP Hypotony
Patients, n (%) 2 1 1 1
(8) (4) (4) (4)
IOP, intraocular pressure.
steroids. One eye, developed hypotony presumably due to either wound leak or a transient cyclodialysis, which resolved spontaneously within 1 month. Table 3 details the long-term complications, defined as occurring within 1 year of surgery. The most common complication was spontaneous IOL dislocation (n = 3, 13%). The initial indication for surgery for each of these three patients was lens dislocation that required IOL exchange. Two IOL dislocations occurred within 3 months, and 1 occurred at 1 year postoperatively. The patient with dislocation at 1 year postoperatively had significant trauma to the eye before the original SSF procedure. This patient developed dislocation of a haptic placed during SSF, which resulted in IOL malposition and two additional surgeries that attempted to first reposition the IOL, and eventually to exchange the lens for an ACIOL. The second patient at 3 months postoperatively had the PCIOL exchanged after subluxation for an ACIOL. The patient has 20/25 vision and has required no further intervention over the past 2 years. The third patient required subsequent surgery to recenter the same IOL placed at the time of the original SSF procedure. This patient had nasal decentration of IOL in left eye 3.5 months after primary procedure. Intraoperatively, we found that the inferotemporal haptic had slipped from its tunnel. An inferotemporal peritomy was performed, and a new tunnel was created. The haptic was repositioned and now 2 years later the IOL remains well centered. All three patients have been doing well without complications thereafter. Another patient developed iris capture of the IOL, 8 days postoperatively, which required an in-office procedure where the lens was maneuvered into the sulcus position using a 30-g needle and pharmacologic dilation. This patient’s IOL has neither migrated
Table 1. Preexisting Conditions Condition Lens dislocation with IOL exchange Lens dislocation with IOL rescue Aphakia with need for secondary IOL Traumatic lens (crystalline) subluxation Corneal decompensation Subluxed crystalline lens
Patients, n (%) 10 8 2 1 2 1
(42) (33) (8) (4) (8) (4)
Table 3. Long-term Postoperative Complications Complication
Patients, n (%)
IOL dislocation Cystoid macular edema Iris capture of IOL
3 (12) 1 (4) 1 (4)
SUTURELESS IOL FIXATION 1-YEAR OUTCOMES WILGUCKI ET AL Table 4. Descriptive Statistics of Visual Acuity LogMAR Preoperative, 3 months Postoperative, and Last Recorded Postoperative: The MEANS Procedure Variable
N
Mean
SD
Median
VA logMAR preoperative VA logMAR 3 months VA logMAR last recorded
24 24 24
1.30 0.69 0.52
0.86 0.62 0.58
1.00 0.40 0.30
nor recaptured since the lens repositioning was performed. One eye (4%) developed cystoid macular edema that was managed medically with sub-Tenon’s triamcinolone acetonide injection 15 weeks after surgery without the need for subsequent surgical intervention. Visual acuity outcomes were calculated using logMAR acuity (visual acuity) for mathematical analysis seen in Table 4. The paired t-test was used to test the difference in the preoperative logMAR visual acuity and each of the postoperative visual acuity measurements at three months and the time of the last recorded vision. Mean logMAR visual acuity preoperatively was 1.30 ± 0.86 (Snellen, 20/399), mean visual acuity 3 months postoperatively was 0.69 ± 0.62 (Snellen 20/97), and the mean last recorded postoperative vision was 0.52 ± 0.58 (Snellen 20/66). There was a significant improvement in mean logMAR visual acuity when comparing preoperative visual acuity to visual acuity 3 months after surgery (P , 0.0094), with a mean difference = 0.58 (95% confidence interval, 0.16– 1.01). There was also significant improvement in mean logMAR visual acuity logMAR when comparing preoperative visual acuity to visual acuity at the last recorded data point. These visual improvements were in accordance with what would be expected after correcting the refractive issues of lens dislocation or aphakia. Discussion We have performed the described SSF technique for the past 3 years and have had reasonable short-term success, which we reported previously.1 The main short-term advantages of this procedure are that a three-piece IOL can be efficiently implanted or rescued into a sulcus-based position, in an efficient, minimally invasive manner, without the need for a fixation suture. Lenses appear to be exceptionally well centered and are stable immediately after fixation. After a brief learning curve, the procedure becomes quickly reliable, efficient, and reproducible. In addition, the procedure allows for a minimally invasive
1039
operation, with case time not exceeding what it takes us to perform the placement of an ACIOL. We had a number of concerns when considering the long-term complications of this procedure and conducted the current research to analyze the longer term outcomes of the operation. Our main concerns surrounded the long-term stability of the IOL position and the risk of haptic erosion either into or out of the intrascleral tunnel. Fortunately, we saw no evidence of haptic erosion and the majority of the IOLs remained well centered after one surgery. Three cases of lens repositioning were required, but we did not identify any common theme with these cases to explain the negative outcomes. One case of IOL dislocation was felt to be the result of an enlarged set of scleral tunnels that did not hug the IOL haptics adequately. Endophthalmitis is a theoretical concern with these cases secondary to a potential track around the intrascleral haptic but this was not seen. We were also concerned about the development of uveitis– glaucoma–hemorrhage syndrome, but this did not occur in our small series. We were pleased to see a reasonable overall success rate at 1 year after SSF for the placement or rescue of a 3-piece IOL. Although this initial success is comforting, we are cautious about long-term stability and complications that may occur years after the initial surgery and look forward to reporting on this study cohort as the time from initial surgery progresses. Key words: intraocular lens, long-term complications, rescue, sutureless scleral fixation, surgical technique. References 1. Prenner JL, Feiner L, Wheatley HM, Connors D. A novel approach for posterior chamber intraocular lens placement or rescue via a sutureless scleral fixation technique. Retina 2012; 32:853–855. 2. Wagner M, Cox T, Ariyasu R, et al. Intraocular lens implantation in absence of capsular support. Ophthalmology 2003; 110:840–859. 3. Dick HB, Augustin AJ. Lens implant selection with absence of capsular support. Curr Opin Ophthalmol 2001;12:47–57. 4. Auffarth GU, Wesendahl TA, Brown SJ, Apple DJ. Are there acceptable anterior chamber intraocular lenses for clinical use in the 1990s? An analysis of 4104 explanted anterior chamber intraocular lenses. Ophthalmology 1994;101:1913–1922. 5. Ellerton CR, Rattigan SM, Chapman FM, et al. Secondary implantation of open-loop, flexible, anterior chamber intraocular lenses. J Cataract Refract Surg 1996;22:951–954. 6. Hennig A, Evans JR, Pradhan D, et al. Randomised controlled trial of anterior-chamber intraocular lenses. Lancet 1997;349: 1129–1133. 7. Asadi R, Kheirkhah A. Long-term results of scleral fixation of posterior chamber intraocular lenses in children. Ophthalmology 2008;115:67–72.
1040 RETINA, THE JOURNAL OF RETINAL AND VITREOUS DISEASES 8. Yen KG, Reddy AK, Weikert MP, et al. Iris-fixated posterior chamber intraocular lenses in children. Am J Ophthalmol 2009;147:121–6. 9. Lanzetta P, Menchini U, Virgili G, et al. Scleral fixated intraocular lenses: an angiographic study. Retina 1998;18: 515–520. 10. Chang JH, Lee JH. Long-term results of implantation of posterior chamber intraocular lens by sulcus fixation. Korean J Ophthalmol 1991;5:42–46.
2015 VOLUME 35 NUMBER 5
11. Navia-Aray EA. Suturing a posterior chamber intraocular lens to the iris through limbal incisions: results in 30 eyes. J Refract Corneal Surg 1994;10:565–570. 12. Buckley EG. Safety of transscleral-sutured intraocular lenses in children. JAAPOS 2008;12:431–439. 13. Scharioth GB, Prasad S, Georgalas I, Tataru C, Pavlidis M. Intermediate results of sutureless intrascleral posterior chamber intraocular lens fixation. J Cataract Refract Surg 2010;36: 254–259.
E
yes that lack sufficient capsular support for intraocular lens (IOL) placement present a unique surgical challenge when IOL implantation or rescue is required. Standard surgical approaches include placement of an anterior chamber IOL (ACIOL) or suture fixation of a posterior chamber IOL (PCIOL) to the iris or sclera. In addition, we have previously reported short-term results of our novel approach to sutureless scleral fixation (SSF) of a three-piece IOL.1 The American Academy of Ophthalmology Ophthalmic Technology Assessment reviewed the standard approaches and found them to be essentially equivalent in terms of eventual visual outcome.2 These well-tested
techniques also have well-documented complications, including the development of glaucoma, intraocular inflammation, corneal decompensation, and suture degradation with IOL dislocation.3–12 In an attempt to avoid the complications of the previously described approaches, we developed a technique that allows for ciliary sulcus-based scleral fixation of a PCIOL without the use of sutures, scleral flaps, or fibrin glue.1 This approach is intended to avoid the anterior chamber complications of ACIOL placement and the risk of IOL malposition secondary to suture failure over time. We significantly modified an anterior segment technique that takes advantage of the surgical instrumentation and the skill set of the posterior segment surgeon.13 These modifications allow for a reproducible and reliable surgical procedure that can be used for both the rescue of a dislocated IOL and for the implantation of a secondary IOL. Sutureless scleral fixation allows for permanent scleral fixation of the polymethylmethacrylate haptics of
From the *Department of Ophthalmology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey; and †Department of Ophthalmology, NJ Retina, New Brunswick, New Jersey. None of the authors have any financial/conflicting interests to disclose. Reprint requests: Jonathan L. Prenner, MD, 10 Plum Street, Suite 600, New Brunswick, NJ 08901; e-mail: jonathanprenner@ gmail.com
1036
SUTURELESS IOL FIXATION 1-YEAR OUTCOMES WILGUCKI ET AL
a three-piece IOL directly into the sclera, eliminating the need for suturing and achieving a position in the ciliary sulcus. Here, we report the 1-year follow-up of 24 eyes that underwent the SSF procedure in an attempt to further evaluate the efficacy and safety of the previously described procedure. Patients and Methods We conducted a retrospective chart review of a consecutive series of 24 eyes of 24 patients who underwent PCIOL implantation or rescue using the SSF technique. Three surgeons (J.L.P., H.M.W., L.F.) performed the identical procedure over a 2-year interval (December 2009 to June 2011). All patients were followed for at least 1 year. Institutional review board approval was obtained before the initiation of this study. Preoperative data captured included visual acuity, intraocular pressure, indication for surgery and the presence of additional ocular comorbidities. Postoperative data collected at Months 3 and 12 included visual acuity, intraocular pressure, IOL position, and the presence of any additional complications. Surgical Technique Here, we briefly describe the surgical technique and have previously demonstrated our surgical procedure in the supplemental digital content from our initial publication.1 A conjunctival peritomy is performed on the temporal 270°, and light scleral cautery is used to achieve adequate hemostasis. After a standard 23-gauge (g) 3-port vitrectomy is performed, 2 ciliary sulcus-based sclerotomies (CSS) are created with a 20-g microvitreoretinal blade. These sclerotomies are made in a parallel orientation, 2 mm from the limbus to achieve a ciliary sulcus location, and are positioned exactly 180° apart at the 6-o’clock and 12-o’ clock positions. This precise positioning is required to assure appropriate lens centration. Then, the blade from the 23-g trochar system is used to create a 3-mm long partial thickness scleral tunnel to connect with each CSS. These tunnels are created parallel to the limbus and must be made in a uniplanar manner. Passing the blade from the temporal to the nasal position helps to avoid challenging hand positions that make creating uniplanar parallel tunnels more difficult. For example, in a left eye, the superior scleral tunnel is started in the opening of the 12-o’clock CSS and passed nasally until blade exits the sclera 3 mm from the CSS. The inferior tunnel is started 3 mm temporally from the 6-o’clock CSS and extended nasally exiting the sclera
1037
in the base of the CSS. The haptics are oriented in the confuration of a backwards S (surgeons view) to confirm that IOL has the proper orientation and tilt as designed. After the tunnels have been created, attention is paid to IOL placement. A disposable 25-g internal limiting membrane forceps is bent 45° to 60° in the middle of the shaft. Actuation of the forceps works well even with this degree of distortion. In aphakic eyes, a 4-mm clear corneal incision is made with a keratome; viscoelastic is injected into the anterior chamber to protect the corneal endothelium. After injection of a 3-piece PCIOL (we typically use the Alcon MA-60AC; Alcon Laboratories Inc, Fort Worth, TX) into the anterior chamber, the bent 25-g forceps is passed through the inferior CSS, and the leading haptic is grasped. The haptic does not need to be engaged at the tip but rather can be engaged anywhere along the distal half of the haptic and is then externalized. It is possible to pull the haptic too forcefully and disengage it from the optic although this is not a common problem. The IOL can then be drawn into the sulcus through the externalized leading haptic. The superior (trailing) haptic is then grasped with the bent 25-g forceps through the superior CSS and externalized in a similar fashion. Because of the 20-g width of the CSS, the haptics bend but will not break during externalization even when not grasped at the tip of the haptic. In cases of a dislocated PCIOL, the IOL is initially freed from any residual capsule using one or two forceps and the vitreous cutter. The discarded capsule is removed with the cutter, and the lens is elevated with a forceps to a position just posterior to the iris plane. The bent 25-g forceps is next passed through the inferior CSS and used to grasp the inferior haptic and externalize it. A similar process is performed to externalize the superior haptic. The scleral tunnels are recanalized with the 25-g forceps because the sclera surrounding the tunnels rehydrates and reestablishing the caliber of the tunnel facilitates haptic implantation. Haptic placement into the tunnel is performed in a temporal-to-nasal direction to assure the most advantageous hand positions and angles. If we again assume that the surgical eye is the left eye, the 25-g forceps is passed through from the distal end of the inferior tunnel into the CSS, first exposing the tip of the forceps through the CSS. The tip of the haptic is then handed from a smooth tying forceps into the open mouth of the 25-g forceps. Once the haptic is engaged, the 25-g forceps is drawn out of the tunnel. The tip of the haptic should be drawn far enough so that it passes through the distal end of the tunnel. For implantation superiorly, the haptic is
1038 RETINA, THE JOURNAL OF RETINAL AND VITREOUS DISEASES
grasped at the tip and is pushed through the tunnel with counter traction applied by a 0.12 mm forceps. The haptic tip should be pushed so that it exits the distal end of the tunnel and is then secured with a tying forceps while the 25-g forceps is removed. Final centration is achieved by manipulation of the haptic tips and the tips are cut flush to the sclera with a scissor. We recommend suturing the CSS with 7-0 Vicryl suture and the 23-g trochar blade wounds and clear corneal incision, if leaking. The conjunctiva can then be closed.
Results A total of 24 patients (15 male, 9 female) met entry criteria and were included in the study cohort. The average age of the study population was 75 years (range, 44–87 years). The indications for surgery in the study cohort are detailed in Table 1. Eighteen eyes (75%) required surgery for lens dislocation, with the other 6 eyes (25%) requiring surgery for other reasons, including aphakia and corneal decompensation. There were a total of 7 patients who underwent SSF between December 2009 and July 2011 who were excluded from the study because they did not fulfill the 1-year follow-up requirement set by the authors. Each one of these patients was individually contacted in attempt to reconnect for follow-up. Five patients refused to comply for a follow-up appointment, one patient moved out of state unable to return to the office and one patient was deceased. Table 2 illustrates the short-term complications experienced by the study cohort. These short-term complications were defined as occurring within 1 month of surgery. Two eyes developed vitreous hemorrhage (8%). One of these eyes was treated with additional vitrectomy, whereas the other resolved spontaneously by the 1-month follow-up examination. One patient who developed elevated intraocular pressure was treated with Combigan that was stopped 3 weeks later after the discontinuation of topical
2015 VOLUME 35 NUMBER 5
Table 2. Short-term Postoperative Complications Complication Vitreous hemorrhage Conjunctival hemorrhage Elevated IOP Hypotony
Patients, n (%) 2 1 1 1
(8) (4) (4) (4)
IOP, intraocular pressure.
steroids. One eye, developed hypotony presumably due to either wound leak or a transient cyclodialysis, which resolved spontaneously within 1 month. Table 3 details the long-term complications, defined as occurring within 1 year of surgery. The most common complication was spontaneous IOL dislocation (n = 3, 13%). The initial indication for surgery for each of these three patients was lens dislocation that required IOL exchange. Two IOL dislocations occurred within 3 months, and 1 occurred at 1 year postoperatively. The patient with dislocation at 1 year postoperatively had significant trauma to the eye before the original SSF procedure. This patient developed dislocation of a haptic placed during SSF, which resulted in IOL malposition and two additional surgeries that attempted to first reposition the IOL, and eventually to exchange the lens for an ACIOL. The second patient at 3 months postoperatively had the PCIOL exchanged after subluxation for an ACIOL. The patient has 20/25 vision and has required no further intervention over the past 2 years. The third patient required subsequent surgery to recenter the same IOL placed at the time of the original SSF procedure. This patient had nasal decentration of IOL in left eye 3.5 months after primary procedure. Intraoperatively, we found that the inferotemporal haptic had slipped from its tunnel. An inferotemporal peritomy was performed, and a new tunnel was created. The haptic was repositioned and now 2 years later the IOL remains well centered. All three patients have been doing well without complications thereafter. Another patient developed iris capture of the IOL, 8 days postoperatively, which required an in-office procedure where the lens was maneuvered into the sulcus position using a 30-g needle and pharmacologic dilation. This patient’s IOL has neither migrated
Table 1. Preexisting Conditions Condition Lens dislocation with IOL exchange Lens dislocation with IOL rescue Aphakia with need for secondary IOL Traumatic lens (crystalline) subluxation Corneal decompensation Subluxed crystalline lens
Patients, n (%) 10 8 2 1 2 1
(42) (33) (8) (4) (8) (4)
Table 3. Long-term Postoperative Complications Complication
Patients, n (%)
IOL dislocation Cystoid macular edema Iris capture of IOL
3 (12) 1 (4) 1 (4)
SUTURELESS IOL FIXATION 1-YEAR OUTCOMES WILGUCKI ET AL Table 4. Descriptive Statistics of Visual Acuity LogMAR Preoperative, 3 months Postoperative, and Last Recorded Postoperative: The MEANS Procedure Variable
N
Mean
SD
Median
VA logMAR preoperative VA logMAR 3 months VA logMAR last recorded
24 24 24
1.30 0.69 0.52
0.86 0.62 0.58
1.00 0.40 0.30
nor recaptured since the lens repositioning was performed. One eye (4%) developed cystoid macular edema that was managed medically with sub-Tenon’s triamcinolone acetonide injection 15 weeks after surgery without the need for subsequent surgical intervention. Visual acuity outcomes were calculated using logMAR acuity (visual acuity) for mathematical analysis seen in Table 4. The paired t-test was used to test the difference in the preoperative logMAR visual acuity and each of the postoperative visual acuity measurements at three months and the time of the last recorded vision. Mean logMAR visual acuity preoperatively was 1.30 ± 0.86 (Snellen, 20/399), mean visual acuity 3 months postoperatively was 0.69 ± 0.62 (Snellen 20/97), and the mean last recorded postoperative vision was 0.52 ± 0.58 (Snellen 20/66). There was a significant improvement in mean logMAR visual acuity when comparing preoperative visual acuity to visual acuity 3 months after surgery (P , 0.0094), with a mean difference = 0.58 (95% confidence interval, 0.16– 1.01). There was also significant improvement in mean logMAR visual acuity logMAR when comparing preoperative visual acuity to visual acuity at the last recorded data point. These visual improvements were in accordance with what would be expected after correcting the refractive issues of lens dislocation or aphakia. Discussion We have performed the described SSF technique for the past 3 years and have had reasonable short-term success, which we reported previously.1 The main short-term advantages of this procedure are that a three-piece IOL can be efficiently implanted or rescued into a sulcus-based position, in an efficient, minimally invasive manner, without the need for a fixation suture. Lenses appear to be exceptionally well centered and are stable immediately after fixation. After a brief learning curve, the procedure becomes quickly reliable, efficient, and reproducible. In addition, the procedure allows for a minimally invasive
1039
operation, with case time not exceeding what it takes us to perform the placement of an ACIOL. We had a number of concerns when considering the long-term complications of this procedure and conducted the current research to analyze the longer term outcomes of the operation. Our main concerns surrounded the long-term stability of the IOL position and the risk of haptic erosion either into or out of the intrascleral tunnel. Fortunately, we saw no evidence of haptic erosion and the majority of the IOLs remained well centered after one surgery. Three cases of lens repositioning were required, but we did not identify any common theme with these cases to explain the negative outcomes. One case of IOL dislocation was felt to be the result of an enlarged set of scleral tunnels that did not hug the IOL haptics adequately. Endophthalmitis is a theoretical concern with these cases secondary to a potential track around the intrascleral haptic but this was not seen. We were also concerned about the development of uveitis– glaucoma–hemorrhage syndrome, but this did not occur in our small series. We were pleased to see a reasonable overall success rate at 1 year after SSF for the placement or rescue of a 3-piece IOL. Although this initial success is comforting, we are cautious about long-term stability and complications that may occur years after the initial surgery and look forward to reporting on this study cohort as the time from initial surgery progresses. Key words: intraocular lens, long-term complications, rescue, sutureless scleral fixation, surgical technique. References 1. Prenner JL, Feiner L, Wheatley HM, Connors D. A novel approach for posterior chamber intraocular lens placement or rescue via a sutureless scleral fixation technique. Retina 2012; 32:853–855. 2. Wagner M, Cox T, Ariyasu R, et al. Intraocular lens implantation in absence of capsular support. Ophthalmology 2003; 110:840–859. 3. Dick HB, Augustin AJ. Lens implant selection with absence of capsular support. Curr Opin Ophthalmol 2001;12:47–57. 4. Auffarth GU, Wesendahl TA, Brown SJ, Apple DJ. Are there acceptable anterior chamber intraocular lenses for clinical use in the 1990s? An analysis of 4104 explanted anterior chamber intraocular lenses. Ophthalmology 1994;101:1913–1922. 5. Ellerton CR, Rattigan SM, Chapman FM, et al. Secondary implantation of open-loop, flexible, anterior chamber intraocular lenses. J Cataract Refract Surg 1996;22:951–954. 6. Hennig A, Evans JR, Pradhan D, et al. Randomised controlled trial of anterior-chamber intraocular lenses. Lancet 1997;349: 1129–1133. 7. Asadi R, Kheirkhah A. Long-term results of scleral fixation of posterior chamber intraocular lenses in children. Ophthalmology 2008;115:67–72.
1040 RETINA, THE JOURNAL OF RETINAL AND VITREOUS DISEASES 8. Yen KG, Reddy AK, Weikert MP, et al. Iris-fixated posterior chamber intraocular lenses in children. Am J Ophthalmol 2009;147:121–6. 9. Lanzetta P, Menchini U, Virgili G, et al. Scleral fixated intraocular lenses: an angiographic study. Retina 1998;18: 515–520. 10. Chang JH, Lee JH. Long-term results of implantation of posterior chamber intraocular lens by sulcus fixation. Korean J Ophthalmol 1991;5:42–46.
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11. Navia-Aray EA. Suturing a posterior chamber intraocular lens to the iris through limbal incisions: results in 30 eyes. J Refract Corneal Surg 1994;10:565–570. 12. Buckley EG. Safety of transscleral-sutured intraocular lenses in children. JAAPOS 2008;12:431–439. 13. Scharioth GB, Prasad S, Georgalas I, Tataru C, Pavlidis M. Intermediate results of sutureless intrascleral posterior chamber intraocular lens fixation. J Cataract Refract Surg 2010;36: 254–259.
