title: Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year.
abstract: BACKGROUND
  To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy.
  
  
  METHODS
  Prospective, non-randomized, comparative study.
  
  
  METHODS
  Sixty-six Asian patients.
  
  
  METHODS
  Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation.
  
  
  METHODS
  The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes.
  
  
  RESULTS
  The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7-19.2) in the Ologen group and 26% (95% confidence interval 14.8-37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8-5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2-7.0 mmHg), respectively (P = 0.16). Needling with 5-fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (<10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs.
  
  
  CONCLUSIONS
  At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. Eyes in the Ologen group required more frequent bleb needling procedures.
authors.affiliation: Singapore National Eye Centre, Singapore.
authors.forename: Arun
authors.initials: A
authors.lastname: Narayanaswamy
authors.forename: Shamira A
authors.initials: SA
authors.lastname: Perera
authors.forename: Hla M
authors.initials: HM
authors.lastname: Htoon
authors.forename: Sek-Tien
authors.initials: ST
authors.lastname: Hoh
authors.forename: Steve K
authors.initials: SK
authors.lastname: Seah
authors.forename: Tina T
authors.initials: TT
authors.lastname: Wong
authors.forename: Tin
authors.initials: T
authors.lastname: Aung
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000477:Alkylating Agents / Q000627:therapeutic use*; D002386:Cataract / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D003094:Collagen; D005260:Female; D005901:Glaucoma / Q000150:complications / Q000503:physiopathology / Q000601:surgery; D006025:Glycosaminoglycans; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D019654:Lens Implantation, Intraocular; D008297:Male; D016685:Mitomycin / Q000627:therapeutic use*; D018918:Phacoemulsification / Q000379:methods*; D011108:Polymers; D011446:Prospective Studies; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000477:Alkylating Agents; D006025:Glycosaminoglycans; D011108:Polymers; C058506:collagen-glycosaminoglycan copolymer; D016685:Mitomycin; D003094:Collagen
keywords: Ologen; collagen implant; glaucoma surgery; wound healing