NCT05043831

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang Trial

Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension in Ethnic Chinese Population The Zhuiguang Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BelkinVision · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the effectiveness (Intra-Ocular Pressure lowering) and safety of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese subjects with Primary Open Angle Glaucoma or Ocular Hypertension.

Detailed description

Glaucoma, which is very common disease in China, can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is. The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT in ethnic Chinese population and determine that it is as effective in reducing intraocular pressure. DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list. Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DEVICE	DSLT	Direct-SLT is applied via the limbus to the trabecular meshwork

Timeline

• Start date: 2021-10-15
• Primary completion: 2023-01-15
• Completion: 2023-04-15
• First posted: 2021-09-14
• Last updated: 2023-05-12