Comparison of trabeculectomy and Ex-PRESS implantation in fellow eyes of the same patient: a prospective, randomised study

Device modified trabeculectomy for glaucoma

“…Five studies assessed the use of trabeculectomy with Ex-PRESS compared with trabeculectomy alone (Dahan 2012;De Jong 2005;De Jong 2009;Netland 2014;Wagschal 2013). Five studies enrolled a total of 412 eyes of 386 participants.…”

“…Funding sources-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.…”

“…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).…”

“…Selective reporting-We judged 16 of 33 studies as being at low risk of reporting bias as they had 1) clinical trial registry records and reported all outcomes listed in the registry (Dahan 2012;Netland 2014;Rosentreter 2010;Rosentreter 2014;Wagschal 2013), or 2) reported all outcome measures defined in the Methods section of the full-text reports (Cho 2013;De Jong 2005;De Jong 2009;Marey 2013;Mitra 2012;Papaconstantinou 2010;Senthil 2013;Sheha 2008;Stavrakas 2012;Wang 2008;Zhang 2009). We judged six studies to have unclear risk of bias because some outcomes that were measured were not reported in primary result papers, but we presume they will be reported in future publications from the trials (Bruno 2008;Cillino 2008;Cillino 2011;Ji 2013;Maheshwari 2012).…”

“…We judged three studies to be at high risk because one did not recruit an adequate number of participants that met the prespecified power requirements of the study (Rosentreter 2010), and two studies received funding from the manufacturer of the device (Dahan 2012;Netland 2014). We judged the remaining studies to be at unclear risk of bias, as methodological details were reported insufficiently to render a judgment of low or high risk of bias.…”