title: Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial.
abstract: OBJECTIVE
  To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy.
  
  
  METHODS
  This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications.
  
  
  RESULTS
  The mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan-Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17  mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted.
  
  
  CONCLUSIONS
  Our results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), Palermo, Italy. cillino@unipa.it
authors.forename: S
authors.initials: S
authors.lastname: Cillino
authors.forename: F
authors.initials: F
authors.lastname: Di Pace
authors.forename: G
authors.initials: G
authors.lastname: Cillino
authors.forename: A
authors.initials: A
authors.lastname: Casuccio
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D003094:Collagen / Q000627:therapeutic use*; D003432:Cross-Linking Reagents / Q000627:therapeutic use*; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000601:surgery*; D006025:Glycosaminoglycans / Q000627:therapeutic use*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000627:therapeutic use*; D011446:Prospective Studies; D019736:Prostheses and Implants; D041623:Tomography, Optical Coherence / Q000379:methods; D014130:Trabeculectomy / Q000379:methods*
chemical_list: D003432:Cross-Linking Reagents; D006025:Glycosaminoglycans; C058506:collagen-glycosaminoglycan copolymer; D016685:Mitomycin; D003094:Collagen