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Enzymatic Sclerostomy
Pilot Human Study
Jacob A. Dan, MD, PhD;
Santosh G. Honavar, MD;
David A. Belyea, MD;
Anil K. Mandal, MD;
Chandrasekhar Garudadri, MD;
Brian Levy, OD, MSc;
Rengappa Ramakrishnan, MD;
Ramasamy Krishnadas, MD;
Marc F. Lieberman, MD;
Robert L. Stamper, MD;
Arieh Yaron, PhD
Arch Ophthalmol. 2002;120:548-553.
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 µg 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.
From Revivim-Zahala Medical Consultants, Tel Aviv, Israel (Dr Dan);
Department of Biophysics and Biochemistry, Weizmann Institute of Science,
Rehovot, Israel (Drs Dan and Yaron); VST Center for Glaucoma Care, LV Prasad
Eye Institute, Hyderabad, India (Drs Honavar, Mandal, and Garudadri); Department
of Ophthalmology, George Washington University, Washington, DC (Drs Dan and
Belyea); Department of Ophthalmology, University of Rochester School of Medicine
& Dentistry, Rochester, NY (Dr Levy); Aravind Eye Hospital, Madurai, India
(Drs Ramakrishnan and Krishnadas); and Department of Ophthalmology, University
of California, San Francisco (Drs Lieberman and Stamper). The Weizmann Institute
of Science, and Drs Dan and Yaron have a proprietary interest in the materials
and the methods used in this study.
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