title: E-PTFE (Gore-Tex) implant with or without low-dosage mitomycin-C as an adjuvant in penetrating glaucoma surgery: 2 year randomized clinical trial.
abstract: OBJECTIVE
  To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy.
  
  
  METHODS
  Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels -< or =21 and < or =17 mmHg - by Kaplan-Meier curves.
  
  
  RESULTS
  The postoperative IOP reduction was significant (P < 0.01) at the endpoint in all groups, with a mean IOP of 16.9 (+/-2.9), 16.2 (+/-2.7), 15.3 (+/-3.4) and 15.2 (+/-4.3) mmHg in T, TMMC, TG and TGMMC eyes, respectively. No intergroup difference was found at either IOP targets. The Kaplan-Meier curves relating to either the < or =21 mmHg or the < or =17 mmHg target IOP did not show significant intergroup differences for complete and qualified success rate. When ePTFE was used, a trend favouring the medium-term survival rate was noted. No adverse reaction to the ePTFE was present, and no membrane extrusion or conjuctival erosion were noted in any cases. Hypotony was significantly more frequent (P = 0.035) in groups without ePTFE. Moreover, the late MMC-related complications were more frequent when MMC was applied.
  
  
  CONCLUSIONS
  Expanded polytetrafluoroethylene implant in trabeculectomy is well tolerated and could act as a filtration modulating device. Therefore, it is useful in reducing early hypotony-related complications and contributes to attaining medium-term IOP control that is comparable to the low-dosage MMC.
authors.affiliation: Department of Clinical Neuroscience, Section of Ophthalmology, University of Palermo, Italy. casuccio@unipa.it
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cillino
authors.forename: Lucio
authors.initials: L
authors.lastname: Zeppa
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Pace
authors.forename: Alessandra
authors.initials: A
authors.lastname: Casuccio
authors.forename: Daniele
authors.initials: D
authors.lastname: Morreale
authors.forename: Fabio
authors.initials: F
authors.lastname: Bocchetta
authors.forename: Gaetano
authors.initials: G
authors.lastname: Lodato
mesh_terms: D000368:Aged; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015814:Ocular Hypotension / Q000209:etiology; D011138:Polytetrafluoroethylene; D011184:Postoperative Period; D019736:Prostheses and Implants; D014130:Trabeculectomy / Q000009:adverse effects
chemical_list: D016685:Mitomycin; D011138:Polytetrafluoroethylene