title: Trabeculectomy using mitomycin C versus an atelocollagen implant: clinical results of a randomized trial and histopathologic findings.
abstract: OBJECTIVE
  To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial.
  
  
  METHODS
  In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied.
  
  
  RESULTS
  Mean preoperative intraocular pressure (IOP) levels (OLO: 28.0 ± 9.4; MMC: 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO: 3.4 ± 1.6; MMC: 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01).
  
  
  CONCLUSIONS
  With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group.
authors.affiliation: Center of Ophthalmology, University of Cologne, Cologne, Germany.
authors.forename: André
authors.initials: A
authors.lastname: Rosentreter
authors.forename: Stergiani
authors.initials: S
authors.lastname: Gaki
authors.forename: Claus
authors.initials: C
authors.lastname: Cursiefen
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Dietlein
mesh_terms: D020341:Absorbable Implants; D000199:Actins / Q000378:metabolism; D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage*; D003094:Collagen; D024061:Collagen Type III / Q000378:metabolism; D003131:Combined Modality Therapy; D005260:Female; D005353:Fibronectins / Q000378:metabolism; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000628:therapy*; D006025:Glycosaminoglycans; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D064828:Prolyl Hydroxylases / Q000378:metabolism; D011446:Prospective Studies; D013524:Surgical Flaps; D014065:Tonometry, Ocular; D014130:Trabeculectomy / Q000379:methods*
chemical_list: D000199:Actins; D000477:Alkylating Agents; D024061:Collagen Type III; D005353:Fibronectins; D006025:Glycosaminoglycans; C058506:collagen-glycosaminoglycan copolymer; D016685:Mitomycin; D003094:Collagen; D064828:Prolyl Hydroxylases