Device-modified trabeculectomy for glaucoma

Record type Uncertainties identified in research recommendations
Source Cochrane Eyes and Vision Group
Why is there uncertainty? Reliable up-to-date systematic reviews have revealed important continuing uncertainties about treatment effects

Original Uncertainty

Implications for Research Low-quality evidence warrants better quality trials to determine the comparative effectiveness of all devices included in this review. These studies are limited and the applicability of the evidence to other population or settings remains unclear. More research is therefore needed to generate evidence for or against devices such as Ex-PRESS, Ologen, amniotic membrane, Gelfilm, E-PTFE, gold micro shunt, and T-flux. In the absence of definitive evidence, we need more trials of better quality for most comparisons and outcomes. These should account for losses to follow-up at each follow-up time point measured. They should also account for the correlation of outcomes between two eyes when applicable. They also need to consider the appropriate use of adjunctive agents, such as mitomycin C in both groups to ensure comparability. It would be helpful for future trials to specify the types of glaucomas, and also to consider stratifying participants by type of glaucoma, and perhaps by lens type, when the sample size is met. We need further research to evaluate the effectiveness and safety of each intervention on patients with different types of glaucoma. Data reporting needs to improve to include reporting of differences between groups to allow more robust inferences when applicable. Future trials should also report on the elements of trial quality identified above and ensure consistency between protocols and published studies.

References to reliable up-to-date systematic reviews:

Wang X, Khan R, Coleman A. Device-modified trabeculectomy for glaucoma. Cochrane Database of Systematic Reviews 2015, Issue 12. Art. No.: CD010472. DOI: 10.1002/14651858.CD010472.pub2

What is needed? Further research
Systematic reviews that need updating or extending None identified
Systematic reviews in preparation None identified
Ongoing controlled trials Ologen (OculusGen)-Glaucoma MMC control trial in India NCT00449098 Oculusgen (Ologen) Glaucoma MMC control in Estonia NCT00524758 Comparative study of the safety and effectiveness of Ologen Collagen Matrix versus mitomycin-C in glaucoma filtering surgery NCT01440751


Which health conditions? Eyes and vision | Glaucoma
What is person's age? Adult
Which types of treatments? Devices | Surgery

Which Outcomes

Change in glaucoma symptoms, or change in management of symptoms (change in vision, blindness, change in intraocular pressure (IOP) at one year, incidence of hypotony ); adverse effects or complications; patient satisfaction; health related quality of life; service related issues; and health related cost

Record ID: Publication date:10 Mar 2016
Last reviewed date:10 Mar 2017 Publication Type:Known Uncertainty
The DUETs team endeavours to ensure that information is correct at the time of data entry