Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial

Abstract

Aim 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 r21, r17, and r15 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 ¼ 0.009). The IOP reduction was significant at end point in all groups (P ¼ 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 (Po0.05). SD-OCT analysis of successful/ unsuccessful bleb in patients with or without complete success at IOP r17 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.

Device modified trabeculectomy for glaucoma

“…Eight studies assessed the use of Ologen (Cillino 2011;Maheshwari 2012;Marey 2013;Mitra 2012;Papaconstantinou 2010;Rosentreter 2010;Rosentreter 2014;Senthil 2013). They enrolled a total of 333 eyes of 327 participants.…”

“…Allocation-Of the 33 studies, 10 specified adequate methods of randomization and we assessed them as being at low risk of bias: three out of five studies for Ex-PRESS (De Jong 2009;Netland 2014;Wagschal 2013), four out of eight studies for Ologen (Cillino 2011;Papaconstantinou 2010;Rosentreter 2014;Senthil 2013), three out of 18 studies for amniotic membrane (Cho 2013;Khairy 2015;Stavrakas 2012). The one study that evaluated E-PTFE did not use a completely random allocation method (medical chart number), so we judged it to be at high risk of bias (Cillino 2008).…”

“…Of the 33 studies, only three performed proper allocation concealment and we judged them to be at low risk of bias: one out of eight studies for Ologen, one out of 18 studies for amniotic membrane, and one study for E-PTFE (Cho 2013;Cillino 2008;Cillino 2011). We judged Khairy 2015 to be at high risk of bias as the investigators labeled the envelope used to allocate the treatment.…”

“…Investigators of one of the 33 studies reported masking of outcome assessors (Cillino 2011) and one study used a special protocol to minimize bias (Netland 2014); we judged these two studies to be at low and unclear risk of detection bias, respectively. None of the other 31 studies specified masking of outcome assessors.…”

“…Incomplete outcome data-Of the 33 studies, investigators of 17 studies reported few or no losses to follow-up, resulting in our assessment of them to be at low risk of attrition bias: four of six trials of Ex-PRESS (Dahan 2012;De Jong 2009;Netland 2014;Wagschal 2013), five of eight studies for Ologen (Cillino 2011;Marey 2013;Papaconstantinou 2010;Rosentreter 2010;Rosentreter 2014), six of 18 studies for amniotic membrane (Cai 2012;Eliezer 2006;Ji 2013;Khairy 2015;Liu 2009;Stavrakas 2012), one study for E-PTFE (Cillino 2008), and one study for Gelfilm (Birt 1998). Four studies had a relatively large percentage of losses to follow-up (> 10%) and we assessed the risk of attrition bias to be high for these studies (Bruno 2008;Cho 2013;Senthil 2013;Sheha 2008).…”