title: Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up.
abstract: BACKGROUND
  Clinical studies comparing trabeculectomy augmented with Ologen implant (OLO) versus trabeculectomy plus mitomycin-C (MMC) show contradictory results. To obtain long-term data, we report an extended 5-year follow-up trial evaluating the safety and efficacy of OLO as adjuvant compared to low-dosage MMC in trabeculectomy.
  
  
  METHODS
  Forty glaucoma patients (40 eyes) assigned to trabeculectomy with MMC or Ologen.
  
  
  METHODS
  target IOP at ≤21, ≤17 and ≤15 mmHg; complete and qualified success endpoint rates.
  
  
  RESULTS
  visual acuity (VA), mean deviation (MD), bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain OCT (SD-OCT) bleb examination; number of glaucoma medications; frequency of postoperative complications.
  
  
  RESULTS
  The mean preoperative IOP was 26.7(±5.2) in MMC and 27.3(±6.0) in OLO eyes. Mean 60-month percentage reduction in IOP was significant in both groups [40.9 (±14.2) and 42.1(±13.3) P = 0.01], with an endpoint value of 15.2 (±3.2) and 15.8 (±2.3) mmHg in MMC and OLO, respectively. Complete success rates at ≤ 21 mmHg target IOP were 65% and 70%, at ≤17 mm Hg 60% and 55%, and at the ≤15 mm Hg target IOP 35% and 45% in MMC and OLO, respectively. The Kaplan-Meier curves did not differ both for complete and qualified success at any target IOP, with no significant endpoint intergroup difference at ≤ 15 mm Hg (log-rank P = 0.595).The intergroup MBGS scores differed due to reduced central and peripheral vascularity in MMC group (P = 0.027; P = 0.041). SD-OCT analysis denied differences in bleb height between MMC vs OLO (140.5 ± 20.3 μ vs 129.2 ± 19.3 μ respectively; P =0.079). Mean antiglaucoma medications were significantly reduced (P < 0.0005) from 2.5 (±0.3) to 1.2 (±0.4) in MMC and from 2.6 (±0.2) to 1.4 (±0.3) in OLO group, with no intergroup differences (P = 0.08). Six (30%) cystic thin avascular blebs without oozing were recorded in the MMC group and 2 (10%) in the OLO group, without intergroup difference (P = 0.235).
  
  
  CONCLUSIONS
  Our extended follow-up results confirm that Ologen implant yields efficacy and long-term success rates quite similar to MMC, with at least equivalent safety.
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), via Liborio Giuffrè, 13, 90127, Palermo, Italy. salvatore.cillino@unipa.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cillino
authors.affiliation: Department of Sciences for Health Promotion and Mother-Child Care "G. D'Alessandro", University of Palermo, Via del Vespro 127, I, 90127, Palermo, Italy. alessandra.casuccio@unipa.it.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Casuccio
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), via Liborio Giuffrè, 13, 90127, Palermo, Italy. francesco.dipace@unipa.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Pace
authors.affiliation: Department of Surgical and Biomedical Sciences, Section of Ophthalmology, University of Perugia, Piazza Menghini 1. S. Andrea delle Fratte, 06156, Perugia, Italy. cagini@unipg.it.
authors.forename: Carlo
authors.initials: C
authors.lastname: Cagini
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), via Liborio Giuffrè, 13, 90127, Palermo, Italy. lucia.ferraro@unipa.it.
authors.forename: Lucia Lee
authors.initials: LL
authors.lastname: Ferraro
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), via Liborio Giuffrè, 13, 90127, Palermo, Italy. giovanni.cillino@unipa.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cillino
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage*; D003094:Collagen; D017889:Exfoliation Syndrome / Q000503:physiopathology / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D006025:Glycosaminoglycans; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence; D014130:Trabeculectomy / Q000379:methods*; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000477:Alkylating Agents; D006025:Glycosaminoglycans; C058506:collagen-glycosaminoglycan copolymer; D016685:Mitomycin; D003094:Collagen