Enzymatic sclerostomy: pilot human study.

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.

• Authors: 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
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 120 Issue 5 Pg. 548-53 (May 2002) ISSN: 0003-9950 [Print] United States
• PMID: 12003602 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Collagenases

Topics

• Aged
• Collagenases (therapeutic use)
• Feasibility Studies
• Female
• Glaucoma, Open-Angle (surgery)
• Humans
• Intraocular Pressure
• Male
• Pilot Projects
• Prospective Studies
• Safety
• Sclera (drug effects)
• Sclerostomy (methods)
• Treatment Outcome