A biomarker for fast progressors in glaucoma?
Progressive lamina cribrosa deformation – A biomarker for fast progressors in glaucoma?
Prof Leung Kai Shun Christopher
168 participants
Jun 1, 2016
Interventional
Conditions
Summary
The study is complied with ICH-GCP. This is a 2-year prospective, multicenter, randomized treatment trial with a primary objective to test whether glaucomatous eyes (receiving not more than one topical IOP lowering medication at the time of recruitment) with observable progressive LC deformation randomized to additional treatment (IOP reduction) have a greater absolute risk reduction (ARR) of VF (primary outcome measure) and RNFL (secondary outcome measure) progression (i.e. the difference in the proportion of eyes with VF/RNFL progression between the additional treatment and continued treatment groups) compared with those without progressive LC deformation randomized to the same manner. In other words, we expect ARR (LC deformation) > ARR (no LC deformation). Eyes without progressive LC deformation are also randomized because they may also demonstrate further VF progression independent of LC deformation and respond to IOP lowering treatment. The comparison between ARR (LC deformation) and ARR (no LC deformation) will afford an objective measure to quantify the relative treatment effect on eyes with detectable LC deformation.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Continued treatment group: Participants will continue to receive the same treatment started before recruitment. Participants reaching any of the end-points, including VF progression, decrease in VA greater than or equal to 2 lines, and IOP greater than 30mmHg on 2 consecutive follow-up visits in anytime during the study period will be excluded from the study and receive additional treatment, which is the same as the additional IOP lowering treatment group. Only the investigator (ophthalmologist)will deliver the intervention.
Locations(1)
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ACTRN12618000826246