Direct selective laser trabeculoplasty for ethnic Chinese with open-angle or normal-tension glaucoma and ocular hypertension
Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension and Normal Tension Glaucoma in Ethnic Chinese Population - The Zhuiguangzhe Trial
This study will try direct selective laser trabeculoplasty (DSLT) to lower eye pressure in ethnic Chinese adults with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | BelkinVision Industry-sponsored |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT05902871 on ClinicalTrials.gov |
What this trial studies
After consent and any required washout of eye pressure medications, eligible participants will receive a single DSLT treatment delivered 360 degrees to the target eye. The first five participants will receive a lower laser energy (1.2 mJ) to confirm early safety, and if safety criteria are met the next cohort of up to 40 participants will receive 1.8 mJ. Participants will return for up to nine follow-up visits, some of which may be remote, with individual participation lasting about 12 months. Outcomes will include safety signals and changes in intraocular pressure over the follow-up period.
Who should consider this trial
Good fit: Ethnic Chinese adults with mild to moderate primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension, good corrected vision (>6/18), able to consent and attend a 12-month follow-up schedule are ideal candidates.
Not a fit: Patients with advanced glaucoma, prior surgery in the study eye, certain eye conditions or medication restrictions, pregnancy, inability to perform reliable visual fields, or those in vision-dependent professions are less likely to benefit or be eligible.
Why it matters
Potential benefit: If successful, DSLT could lower intraocular pressure and reduce reliance on daily glaucoma medications or the need for earlier surgery.
How similar studies have performed: Conventional selective laser trabeculoplasty (SLT) has established effectiveness for lowering eye pressure, and DSLT is a newer automated variation with early positive but more limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Chinese ethnicity with corrected visual acuity greater than 6/18 in both eyes. * Diagnosed with mild to moderate primary open angle glaucoma, ocular hypertension, or normal tension open angle glaucoma. * Willing and able to participate in a 12-month study, comply with the study procedures, and adhere to the follow-up schedule. * Capable of giving informed consent. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Eye conditions as specified in the protocol. * Use of medications as specified in the protocol. * Unable to provide a reliable visual field test. * Women who are pregnant or may become pregnant during the study. * Prior surgery in the study eye. * In a vision-dependent profession such as pilot or commercial driver. * Other protocol-specified exclusion criteria may apply.
Where this trial is running
Hong Kong and 1 other locations
- C-Mer Eye Clinic — Hong Kong, China (Completed)
- Seri — Singapore, Singapore (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.