NCT05902871

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

Direct Selective Laser Trabeculoplasty for Primary Open Angle Glaucoma and Ocular Hypertension and Normal Tension Glaucoma in Ethnic Chinese Population - The Zhuiguangzhe Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: BelkinVision · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).

Detailed description

After informed consent is obtained, potential study participants will undergo a hypotensive medication washout period as applicable. Patients will then be re-assessed for eligibility and treated with DSLT if they meet the inclusion/exclusion criteria. The first 5 patients will be treated 360 degrees with laser energy of 1.2 millijoule (mJ) (Group 1). If all 5 Group 1 patients pass the pre-defined safety endpoint at Week 1, then the next 40 patients will be treated 360 degrees with laser energy of 1.8 mJ (Group 2). Patients will attend one treatment visit and up to 9 follow-up visits, remotely or at the clinic. Individual duration of participation is approximately 12 months.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension
• Normal Tension Glaucoma

Interventions

Type	Name	Description
DEVICE	External Automatic Glaucoma Laser	Trans-limbal, direct selective laser trabeculoplasty (DSLT) instrument that directs laser energy through the sclera around the limbus overlying the trabecular meshwork and treats 360 degrees of the angle is treated simultaneously
PROCEDURE	Direct Selective Laser Trabeculoplasty	Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-10-01
• Completion: 2027-03-01
• First posted: 2023-06-15
• Last updated: 2025-12-16

Locations

2 sites across 2 countries: China, Singapore