Original Investigation
Fixation of Extraocular Muscles to Porous Orbital Implants Using 2-Ocetyl-Cyanoacrylate Glue Daniel Warder, M.D. and Vladimir Kratky, M.D., F.R.C.S.C. Queen’s University, Kingston, Ontario, Canada
Purpose: To assess the efficacy of recti muscle fixation with 2-ocetyl-cyanoacrylate tissue glue to porous orbital implants in human subjects undergoing enucleation. Methods: This was a prospective interventional study with a historical control group. Over a 1-year period, patients who received orbital implant fixation using 2-ocetyl-cyanoacrylate tissue glue were enrolled in the study. Functional assessment was carried out by measurement of implant motility at the 6-month postoperative period, which was compared with a historical control group of patients with sutured implants. Structural assessment was carried out with a random sample of orbital MRIs. Results: Twelve patients received the glue-fixation technique. There were no intraoperative or immediate postoperative complications. There was no statistically significant difference between the glued and sutured groups’ horizontal implant movement (7.0 mm ± 1.5 mm vs. 6.8 mm ± 1.8 mm, respectively; p = 0.85) or vertical implant movement (5.6 mm ± 1.7 mm vs. 5.0 mm ± 1.4 mm, respectively; p = 0.39). Sample orbital MRI demonstrated good muscle approximation to the implants as well as contrast enhancement suggestive of successful fibrovascular proliferation. Conclusions: Recti muscle fixation using 2-ocetyl-cyanoacrylate tissue glue to porous orbital implants appeared safe and produced good functional and structural results in this proofof-concept study. This novel technique of implant fixation may offer benefits in terms of reduced operating room time and cost savings. (Ophthal Plast Reconstr Surg 2015;31:275–277)
C
yanoacrylate tissue glue is a synthetic adhesive used extensively for many surgical applications. It has many favorable properties such as high bond strength, rapid polymerization time, and low cost. 2-Ocetyl-cyanoacrylate consists of a longer chain polymer compared with other cyanoacrylate glues conferring more pliability and less brittleness to its bond. This property makes it an ideal adhesive where tissue movement is present. Approved in 1998 by the Food and Drug Administration for the closure of traumatic and surgical wounds, 2-ocetyl-cyanocarylate is most commonly used for this purpose; however, it is also safely used internally for various purposes including
Accepted for publication July 23, 2014. Presented at the Canadian Ophthalmological Society Annual Meeting on June 2013 in Montreal, QC, Canada. The authors have no financial or conflicts of interest to disclose. Address correspondence and reprint requests to Vladimir Kratky, M.D., F.R.C.S.C., Queen’s University, 166 Brock Street, Kingston, ON, Canada K7L 5G2. E-mail: [email protected] DOI: 10.1097/IOP.0000000000000305
Ophthal Plast Reconstr Surg, Vol. 31, No. 4, 2015
embolization of gastrointestinal varices1 or arteriovenous malformations,2 repair of cerebrospinal fluid leaks,3 fixation of fractures,4,5 myringoplasty,6 and fixation of internal surgical mesh during laparoscopic hernia repair.7 In the field of ophthalmology, cyanoacrylate is most commonly used in the treatment of small corneal perforations for which is has become the standard; however, it is also used for many other indications in anterior segment and periocular surgery,8 as well as in the fixation of extraocular muscles to sclera during strabismus surgery without complication.9,10 In the setting of orbital implant surgery, cyanoacrylate fixation of extraocular muscles to porous orbital implants has been demonstrated in animal studies.11,12 Gupta et al. implanted hydroxyapatite and polyethylene balls into rabbit sockets using 2-ocetyl-cyanoacrylate muscle fixation and found that 6-week postprocedure, all muscles were incorporated into the implants by fibrovascular tissue with a tensile strength similar to suturefixated muscles. There were no complications related to the glue. Barbarini et al. showed that 2-ocetyl-cyanoacrylate fixation of extraocular muscles to polyethylene implants in rabbits yields a strong bond with no impediment to fibrovascular incorporation into the implant, no residual glue detectable at 90 days postimplantation, and no noted side effects. The traditional method of fixing extraocular muscles to orbital implants after enucleation involves suturing the muscle tendon to a material wrapped around an implant, such as donor sclera or vicryl mesh. This step of the procedure is technically more involved and time consuming. It has been estimated that approximately 30 minutes of operating room time could be saved per enucleation case using a glue-fixation technique.11 This relates to a shorter and thus safer anesthetic for the patient as well as significant cost savings for the healthcare system. The purpose of the present study is to demonstrate the efficacy of extraocular muscle fixation to porous orbital implants using 2-ocetyl-cyanoacrylate tissue glue in human patients undergoing enucleation.
METHODS This is a prospective, single-center, interventional study with a historical control group. Patients were recruited during a 1-year period from the Oculoplastics Service at the Department of Ophthalmology, Queen’s University. Patients scheduled for an enucleation with primary implantation of a porous implant were invited to participate. The inclusion criteria included age more than 18 years and ability to give informed consent. The exclusion criteria included age less than 18 years or any known sensitivity/allergy to cyanoacrylate glue. The Research Ethics Board at Queen’s University approved the study before patient enrollment. Surgical Technique. All enucleations were carried out under general anesthetic or with sedation under monitored anesthetic care. A retrobulbar injection (50:50 mixture of 1% lidocaine with epinephrine and bupivacaine 0.5%) was administered at the beginning of the case.
275
Copyright © 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc. Unauthorized reproduction of this article is prohibited.
Ophthal Plast Reconstr Surg, Vol. 31, No. 4, 2015
D. Warder and V. Kratky
A standard 360° conjunctival peritomy followed by blunt dissection into all 4 quadrants was carried out with Westcott scissors. A muscle hook was used to isolate the rectus muscle whose fascial attachments were removed with a combination of blunt and sharp dissection. A bulldog surgical clamp was used to secure the muscle at the tendinous insertion before disinsertion from the globe using scissors. This step was carried out on all four recti muscles. The globe was secured with a surgical snap anchored to one of the recti stumps and the optic nerve crushed with an optic nerve clamp for 5 minutes. The optic nerve was then cut with enucleation scissors, and the globe was removed from the orbit while the remaining oblique muscles were disinserted. Hemostasis was achieved with a combination of manual pressure and bipolar cautery. An appropriately sized unwrapped porous implant (Medpor, Stryker, Kalamazoo, MI) was soaked in gentamicin and then inserted into the orbit with the aid of a cut fingertip of a sterile glove liner so as to not drag surrounding tissue with it. 2-Ocetyl-cyanocrylate (Dermabond, Ethicon, Blue Ash, OH) was drawn up into a tuberculin syringe, and a 27-gauge needle was used for precise glue delivery. Sterile cotton swabs were used to dry the muscle tendon and the orbital implant surface, and then a small amount of glue was applied to the underside of the muscle tendon that was then placed on the anterior exposed surface of the orbital implant. Pressure was used to hold the muscle in place using a capped sterile marking pen for approximately 20 to 30 seconds while polymerization took place. Moderate manual traction on the muscle using forceps ensured adequate fixation. These steps were then repeated for the remaining 3 recti muscles. A standard 2-layer closure of Tenon’s capsule and conjunctiva was carried out using vicryl sutures. An antibiotic ointment was instilled into the socket and a conformer put into place followed by a pressure patch. Patients were clinically assessed at 3 days, 2 weeks, 3 months, and 6 months postoperatively. Functional assessment was carried out by measurement of implant motility at least 6 months after surgery. This was done by marking the conjunctiva with a surgical marking pen over the center of the implant, and measuring horizontal and vertical movements with a ruler. The average of 3 measurements was used. These measurements were compared with a historical control group of patients who had enucleations in the past and had received a traditional muscle fixation technique using vicryl sutures to a vicryl mesh-wrapped implant. Structural assessment of a random selection of patients was carried out with orbital MRI.
RESULTS During a 1-year period, 12 patients underwent enucleation with the 2-ocetyl-cyanoacrylate glue technique of muscle fixation. The indications for enucleation included blind painful eye due to end-stage glaucoma (n = 4), chronic retinal detachment (n = 2), trauma (n = 3), corneal melt (n = 1), and ciliary body melanoma (n = 2). There were no intraoperative complications, and all muscles were felt to be adequately bonded to the implants before closing the Tenon’s capsule and conjunctiva. There were no complications in the immediate postoperative period, including no excessive inflammation, infection, or implant extrusion. One case did suffer from poor wound healing and eventual wound dehiscence at the
2-week postoperative period with minor implant exposure. He eventually required a dermis fat graft to repair the defect due to prolonged poor healing. Notably, this patient did have liver cirrhosis due to chronic alcoholism, which may have contributed to poor wound healing. Implant motility was judged to be good with no cases demonstrating lack of movement (Table). The mean duration from surgery to implant motility measurement in the glued group was 7 months compared with 42 months in the historical control/sutured group (p
Fixation of Extraocular Muscles to Porous Orbital Implants Using 2-Ocetyl-Cyanoacrylate Glue Daniel Warder, M.D. and Vladimir Kratky, M.D., F.R.C.S.C. Queen’s University, Kingston, Ontario, Canada
Purpose: To assess the efficacy of recti muscle fixation with 2-ocetyl-cyanoacrylate tissue glue to porous orbital implants in human subjects undergoing enucleation. Methods: This was a prospective interventional study with a historical control group. Over a 1-year period, patients who received orbital implant fixation using 2-ocetyl-cyanoacrylate tissue glue were enrolled in the study. Functional assessment was carried out by measurement of implant motility at the 6-month postoperative period, which was compared with a historical control group of patients with sutured implants. Structural assessment was carried out with a random sample of orbital MRIs. Results: Twelve patients received the glue-fixation technique. There were no intraoperative or immediate postoperative complications. There was no statistically significant difference between the glued and sutured groups’ horizontal implant movement (7.0 mm ± 1.5 mm vs. 6.8 mm ± 1.8 mm, respectively; p = 0.85) or vertical implant movement (5.6 mm ± 1.7 mm vs. 5.0 mm ± 1.4 mm, respectively; p = 0.39). Sample orbital MRI demonstrated good muscle approximation to the implants as well as contrast enhancement suggestive of successful fibrovascular proliferation. Conclusions: Recti muscle fixation using 2-ocetyl-cyanoacrylate tissue glue to porous orbital implants appeared safe and produced good functional and structural results in this proofof-concept study. This novel technique of implant fixation may offer benefits in terms of reduced operating room time and cost savings. (Ophthal Plast Reconstr Surg 2015;31:275–277)
C
yanoacrylate tissue glue is a synthetic adhesive used extensively for many surgical applications. It has many favorable properties such as high bond strength, rapid polymerization time, and low cost. 2-Ocetyl-cyanoacrylate consists of a longer chain polymer compared with other cyanoacrylate glues conferring more pliability and less brittleness to its bond. This property makes it an ideal adhesive where tissue movement is present. Approved in 1998 by the Food and Drug Administration for the closure of traumatic and surgical wounds, 2-ocetyl-cyanocarylate is most commonly used for this purpose; however, it is also safely used internally for various purposes including
Accepted for publication July 23, 2014. Presented at the Canadian Ophthalmological Society Annual Meeting on June 2013 in Montreal, QC, Canada. The authors have no financial or conflicts of interest to disclose. Address correspondence and reprint requests to Vladimir Kratky, M.D., F.R.C.S.C., Queen’s University, 166 Brock Street, Kingston, ON, Canada K7L 5G2. E-mail: [email protected] DOI: 10.1097/IOP.0000000000000305
Ophthal Plast Reconstr Surg, Vol. 31, No. 4, 2015
embolization of gastrointestinal varices1 or arteriovenous malformations,2 repair of cerebrospinal fluid leaks,3 fixation of fractures,4,5 myringoplasty,6 and fixation of internal surgical mesh during laparoscopic hernia repair.7 In the field of ophthalmology, cyanoacrylate is most commonly used in the treatment of small corneal perforations for which is has become the standard; however, it is also used for many other indications in anterior segment and periocular surgery,8 as well as in the fixation of extraocular muscles to sclera during strabismus surgery without complication.9,10 In the setting of orbital implant surgery, cyanoacrylate fixation of extraocular muscles to porous orbital implants has been demonstrated in animal studies.11,12 Gupta et al. implanted hydroxyapatite and polyethylene balls into rabbit sockets using 2-ocetyl-cyanoacrylate muscle fixation and found that 6-week postprocedure, all muscles were incorporated into the implants by fibrovascular tissue with a tensile strength similar to suturefixated muscles. There were no complications related to the glue. Barbarini et al. showed that 2-ocetyl-cyanoacrylate fixation of extraocular muscles to polyethylene implants in rabbits yields a strong bond with no impediment to fibrovascular incorporation into the implant, no residual glue detectable at 90 days postimplantation, and no noted side effects. The traditional method of fixing extraocular muscles to orbital implants after enucleation involves suturing the muscle tendon to a material wrapped around an implant, such as donor sclera or vicryl mesh. This step of the procedure is technically more involved and time consuming. It has been estimated that approximately 30 minutes of operating room time could be saved per enucleation case using a glue-fixation technique.11 This relates to a shorter and thus safer anesthetic for the patient as well as significant cost savings for the healthcare system. The purpose of the present study is to demonstrate the efficacy of extraocular muscle fixation to porous orbital implants using 2-ocetyl-cyanoacrylate tissue glue in human patients undergoing enucleation.
METHODS This is a prospective, single-center, interventional study with a historical control group. Patients were recruited during a 1-year period from the Oculoplastics Service at the Department of Ophthalmology, Queen’s University. Patients scheduled for an enucleation with primary implantation of a porous implant were invited to participate. The inclusion criteria included age more than 18 years and ability to give informed consent. The exclusion criteria included age less than 18 years or any known sensitivity/allergy to cyanoacrylate glue. The Research Ethics Board at Queen’s University approved the study before patient enrollment. Surgical Technique. All enucleations were carried out under general anesthetic or with sedation under monitored anesthetic care. A retrobulbar injection (50:50 mixture of 1% lidocaine with epinephrine and bupivacaine 0.5%) was administered at the beginning of the case.
275
Copyright © 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc. Unauthorized reproduction of this article is prohibited.
Ophthal Plast Reconstr Surg, Vol. 31, No. 4, 2015
D. Warder and V. Kratky
A standard 360° conjunctival peritomy followed by blunt dissection into all 4 quadrants was carried out with Westcott scissors. A muscle hook was used to isolate the rectus muscle whose fascial attachments were removed with a combination of blunt and sharp dissection. A bulldog surgical clamp was used to secure the muscle at the tendinous insertion before disinsertion from the globe using scissors. This step was carried out on all four recti muscles. The globe was secured with a surgical snap anchored to one of the recti stumps and the optic nerve crushed with an optic nerve clamp for 5 minutes. The optic nerve was then cut with enucleation scissors, and the globe was removed from the orbit while the remaining oblique muscles were disinserted. Hemostasis was achieved with a combination of manual pressure and bipolar cautery. An appropriately sized unwrapped porous implant (Medpor, Stryker, Kalamazoo, MI) was soaked in gentamicin and then inserted into the orbit with the aid of a cut fingertip of a sterile glove liner so as to not drag surrounding tissue with it. 2-Ocetyl-cyanocrylate (Dermabond, Ethicon, Blue Ash, OH) was drawn up into a tuberculin syringe, and a 27-gauge needle was used for precise glue delivery. Sterile cotton swabs were used to dry the muscle tendon and the orbital implant surface, and then a small amount of glue was applied to the underside of the muscle tendon that was then placed on the anterior exposed surface of the orbital implant. Pressure was used to hold the muscle in place using a capped sterile marking pen for approximately 20 to 30 seconds while polymerization took place. Moderate manual traction on the muscle using forceps ensured adequate fixation. These steps were then repeated for the remaining 3 recti muscles. A standard 2-layer closure of Tenon’s capsule and conjunctiva was carried out using vicryl sutures. An antibiotic ointment was instilled into the socket and a conformer put into place followed by a pressure patch. Patients were clinically assessed at 3 days, 2 weeks, 3 months, and 6 months postoperatively. Functional assessment was carried out by measurement of implant motility at least 6 months after surgery. This was done by marking the conjunctiva with a surgical marking pen over the center of the implant, and measuring horizontal and vertical movements with a ruler. The average of 3 measurements was used. These measurements were compared with a historical control group of patients who had enucleations in the past and had received a traditional muscle fixation technique using vicryl sutures to a vicryl mesh-wrapped implant. Structural assessment of a random selection of patients was carried out with orbital MRI.
RESULTS During a 1-year period, 12 patients underwent enucleation with the 2-ocetyl-cyanoacrylate glue technique of muscle fixation. The indications for enucleation included blind painful eye due to end-stage glaucoma (n = 4), chronic retinal detachment (n = 2), trauma (n = 3), corneal melt (n = 1), and ciliary body melanoma (n = 2). There were no intraoperative complications, and all muscles were felt to be adequately bonded to the implants before closing the Tenon’s capsule and conjunctiva. There were no complications in the immediate postoperative period, including no excessive inflammation, infection, or implant extrusion. One case did suffer from poor wound healing and eventual wound dehiscence at the
2-week postoperative period with minor implant exposure. He eventually required a dermis fat graft to repair the defect due to prolonged poor healing. Notably, this patient did have liver cirrhosis due to chronic alcoholism, which may have contributed to poor wound healing. Implant motility was judged to be good with no cases demonstrating lack of movement (Table). The mean duration from surgery to implant motility measurement in the glued group was 7 months compared with 42 months in the historical control/sutured group (p
