Trabeculectomy Using Mitomycin C versus an Atelocollagen Implant: Clinical Results of a Randomized Trial and Histopathologic Findings

Abstract

Purpose: 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.

Ex-PRESS outcomes using mitomycin-C, Ologen alone, Ologen with 5-fluorouracil

“…This ethical consideration led to a small sample size in the Ologen only group. The suboptimal performance of Ologen alone compared with MMC or Ologen with 5-FU is consistent with previous reports showing patients who receive MMC rather than Ologen have significantly lower IOP at 12 months [12][13][14]. This finding was also reinforced recently in a meta-analysis showing that patients undergoing trabeculectomy with MMC rather than Ologen experienced on average 1.94 mm Hg greater reduction in IOP, and that this difference was statistically significant [15].…”

“…The effectiveness of Ologen in clinical practice remains controversial with some studies showing equivalent results to MMC [8][9][10], others showing higher rates of complications [11], and others was showing lower pressure reductions than MMC [12][13][14]. A recent meta-analysis showed greater IOP reduction with MMC that was significant at 12 months follow-up, but noted the persistent scarcity of comparative studies with Ologen [15].…”

Device-modified trabeculectomy for glaucoma

“…Of the 33 studies, the funding source of seven studies had been reported: six studies were supported by industry (Dahan 2012; De Jong 2009; Netland 2014; Rosentreter 2010; Rosentreter 2014; Wagschal 2013) and one study reported receiving no funding (Senthil 2013). Reports from the other 26 studies did not disclose information about sources of funding.…”

“…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, 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).…”