RecruitingPhase 3Phase 4ACTRN12618000826246

A biomarker for fast progressors in glaucoma?

Progressive lamina cribrosa deformation – A biomarker for fast progressors in glaucoma?


Sponsor

Prof Leung Kai Shun Christopher

Enrollment

168 participants

Start Date

Jun 1, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Glaucoma is a leading cause of irreversible blindness worldwide. The optic nerve damage it causes progresses at very different rates in different people — some patients lose vision quickly while others remain stable for decades. Identifying which patients are "fast progressors" early is crucial so that more aggressive treatment can be applied before significant vision loss occurs. This study is investigating whether a structural change called "lamina cribrosa deformation" — a bowing of the optic disc tissue visible on specialised imaging — can predict who is at highest risk of rapid vision loss. Patients with primary open-angle glaucoma (the most common form) will be randomly assigned to receive either additional eye pressure-lowering treatment or to continue at their current treatment level. Researchers will then track whether the patients with visible lamina cribrosa deformation benefit more from the extra treatment than those without it — helping to validate this imaging feature as a practical clinical tool. You may be eligible if you are 18 or older, have been followed for open-angle glaucoma for at least 36 months at Hong Kong Eye Hospital, are on no more than one pressure-lowering eye drop, and have not previously had glaucoma laser or surgical procedures. People with very high eye pressure, severe visual field loss, or diabetes affecting the eyes are not eligible. The study runs over two years with regular vision assessments.

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 g

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)

Hong Kong

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