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Enzymatic sclerostomy: pilot human study.

Jacob A Dan·Santosh G Honavar·David A Belyea·Anil K Mandal·Chandrasekhar Garudadri·Brian Levy·Rengappa Ramakrishnan·Ramasamy Krishnadas·Marc F Lieberman·Robert L Stamper·Arieh Yaron
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Abstract

OBJECTIVE: To evaluate the feasibility and safety of enzymatic sclerostomy as a new modality to lower intraocular pressure in patients with open-angle glaucoma. METHODS: This single-center, prospective, noncomparative, interventional case series included 15 blind symptomatic eyes of 15 patients with primary open-angle glaucoma. Enzymatic sclerostomy was performed with the patient under topical or peribulbar anesthesia. A specially designed polymethylmethacrylate enzyme applicator filled with a mean +/- SD of 123 +/- 13 microg of collagenase was introduced through a 5-mm peritomy, and affixed to the limbus by means of cyanoacrylate tissue glue. After 22 to 24 hours, the applicators were removed and the patients were followed up for 1 year. Intraocular pressure changes from baseline and complications related to the procedure were the main outcome measures. RESULTS: Controlled thinning of the treated sclera associated with aqueous percolation and shallow filtration bleb was seen in all eyes in the immediate postoperative period. The mean +/- SD intraocular pressure decreased from 43.5 +/- 9.8 mm Hg (while the patients were receiving a mean +/- SD of 1.75 +/- 0.75 antiglaucoma medications) preoperatively to 24.8 +/- 10.6 mm Hg (a 43.0% decrease from baseline with no antiglaucoma medication) on the first postoperative day and to 34.8 +/- 10.5 mm Hg (a 20.0% decrease from baseline with no antiglaucoma medication) at the end of 1 year. Ophthalmic adverse effects were limited to the treated area and included immediate postoperative transient conjunctival reaction ranging from mild chemosis to conjunctival maceration. Immediate full-thickness perforation developed in 1 eye; the patient was treated and excluded from data analysis. Two eyes developed symptoms related to increase in intraocular pressure after 9 months; the patients were treated and excluded from further data analysis. No systemic complications were noted. CONCLUSIONS: Enzymatic sclerostomy demonstrated immediate and sustained intraocular pressure reduction and provided symptomatic relief in blind eyes with primary open-angle glaucoma. The procedure, however, needs further technical refinement.

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AgedCollagenasesFeasibility StudiesFemaleGlaucoma, Open-AngleHumansIntraocular PressureMalePilot ProjectsProspective StudiesSafetyScleraSclerostomyTreatment OutcomeClinical TrialJournal ArticleResearch Support, Non-U.S. Gov't

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Jacob A Dan, Santosh G Honavar, David A Belyea, Anil K Mandal, Chandrasekhar Garudadri, Brian Levy, Rengappa Ramakrishnan, Ramasamy Krishnadas, Marc F Lieberman, Robert L Stamper, Arieh Yaron. 2002. Enzymatic sclerostomy: pilot human study.. https://doi.org/10.1001/archopht.120.5.548

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