Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up

BMC Ophthalmology, Mar 2016

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. Primary outcome: target IOP at ≤21, ≤17 and ≤15 mmHg; complete and qualified success endpoint rates. Secondary outcomes: 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.

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Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up

Cillino et al. BMC Ophthalmology Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up Salvatore Cillino 0 3 Alessandra Casuccio 2 Francesco Di Pace 0 3 Carlo Cagini 1 Lucia Lee Ferraro 0 3 Giovanni Cillino 0 3 0 Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy) , via Liborio Giuffrè, 13, 90127 Palermo , Italy 1 Department of Surgical and Biomedical Sciences, Section of Ophthalmology, University of Perugia , Piazza Menghini 1. S. Andrea delle Fratte, 06156 Perugia , Italy 2 Department of Sciences for Health Promotion and Mother-Child Care “G. D'Alessandro”, University of Palermo , Via del Vespro 127, I, 90127 Palermo , Italy 3 Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy) , via Liborio Giuffrè, 13, 90127 Palermo , Italy 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. Primary outcome: target IOP at ≤21, ≤17 and ≤15 mmHg; complete and qualified success endpoint rates. Secondary outcomes: 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. Mitomycin-C; Ologen; Trabeculectomy; Extended 5-yrs follow-up Background Trabeculectomy with mitomycin-C (MMC) today is still regarded as the gold-standard in glaucoma surgery. Yet, in many studies MMC-related complications such as prolonged wound leaks, hypotony with choroidal effusions and maculopathy, thin avascular blebs, and/or bleb leaks with late infection are frequently reported [ 1–9 ]. A biodegradable collagen-glycosaminoglycan copolymer matrix implant (Ologen®) has been proposed as an alternative adjuvant, used as a spacer to mechanically separate the sub conjunctival and episcleral tissues to preventing fibrosis, and also helps in reorganizing the subconjunctival scar formation. In fact, it should induce fibroblasts and myofibroblasts to grow randomly into its porous structure and secrete a loose connectival matrix, reducing the scarring degree. The implant is recommended to be placed subconjunctivally over the scleral flap posteriorly and possibly a small portion covering the scleral flap, else the ologen disc would act as a mechanical tamponade and prevent fluid outflow from the sub scleral space. In 2010, a medium-term RCT did not show any intraocular pressure-lowering advantage of the Ologenaugmented trabeculectomy vs trabeculectomy alone, with a higher yet not significant incidence of complications with the collagen implant [ 10 ]. In the same year another randomized study of MMC-augmented trabeculectomy vs trabeculectomy using Ologen showed a lower complete success rate but a lower bleb-associated complication rate in Ologen group [ 11 ]. In 2011, we published the results of a 24-month, randomized prospective clinical trial on Ologen implant vs MMC in trabeculectomy [ 12 ]. The intraocular pressure (IOP) reduction was significant at endpoint in all groups (P = 0.01). The rates and Kaplan–Meier curves did not differ for (...truncated)


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Salvatore Cillino, Alessandra Casuccio, Francesco Di Pace, Carlo Cagini, Lucia Ferraro, Giovanni Cillino. Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up, BMC Ophthalmology, 2016, pp. 24, 16, DOI: 10.1186/s12886-016-0198-0