title: 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: PO Box 38, Hod-Hasharon 45100, Israel. jdan@netvision.net.il
authors: Jacob A
authors: JA
authors: Dan
authors: Santosh G
authors: SG
authors: Honavar
authors: David A
authors: DA
authors: Belyea
authors: Anil K
authors: AK
authors: Mandal
authors: Chandrasekhar
authors: C
authors: Garudadri
authors: Brian
authors: B
authors: Levy
authors: Rengappa
authors: R
authors: Ramakrishnan
authors: Ramasamy
authors: R
authors: Krishnadas
authors: Marc F
authors: MF
authors: Lieberman
authors: Robert L
authors: RL
authors: Stamper
authors: Arieh
authors: A
authors: Yaron
mesh_terms: D000368:Aged; D017364:Collagenases / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D005902:Glaucoma, Open-Angle / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D012449:Safety; D012590:Sclera / Q000187:drug effects*; D012599:Sclerostomy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D017364:Collagenases