title: Adjunctive Mitomycin C or Amniotic Membrane Transplantation for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial.
abstract: To determine whether adjunctive mitomycin C (MMC) or amniotic membrane transplantation (AMT) improve the outcomes of Ahmed glaucoma valve (AGV) implantation.
  
  
  
  This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 patients aged 7 to 75 years with refractory glaucoma. Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with MMC (group B, 25 eyes), and AGV with AMT (group C, 25 eyes).
  
  
  
  The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 patients including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the MMC group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. Hypertensive phase was slightly but insignificantly more common with standard surgery (82%) as compared with MMC-augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28).
  
  
  
  Although adjunctive MMC and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including hypertensive phase, were also comparable.
authors.affiliation: *Ocular Tissue Engineering Research Center †Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Shahin
authors.initials: S
authors.lastname: Yazdani
authors.forename: Hassan
authors.initials: H
authors.lastname: Mahboobipour
authors.forename: Mohammad
authors.initials: M
authors.lastname: Pakravan
authors.forename: Azadeh
authors.initials: A
authors.lastname: Doozandeh
authors.forename: Elham
authors.initials: E
authors.lastname: Ghahari
mesh_terms: D000328:Adult; D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage*; D000650:Amnion / Q000637:transplantation*; D004311:Double-Blind Method; D005260:Female; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D011183:Postoperative Complications; D019919:Prosthesis Implantation / Q000379:methods; D014065:Tonometry, Ocular; D016896:Treatment Outcome
chemical_list: D000477:Alkylating Agents; D016685:Mitomycin