Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

Not Applicable

Recruiting

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

• Registration Number: NCT05902871
• Lead Sponsor: BelkinVision

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2024-03-11
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in IOP at Month 6	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6	Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at Month 6 for each participant enrolled in the study. A negative change from baseline will represent an improvement.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12	Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at the respective timepoints (Month 6 and Month 12). A positive percent reduction will represent an improvement.
Proportion of Subjects with at least 20 percent reduction in IOP from Baseline in IOP for POAG and OHT and at least 15 percent reduction in IOP for NTG at Month 6 with no Secondary Surgical Intervention (SSI) or Inability to Washout	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12	Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). A secondary surgical intervention (SSI) is defined as a procedure in addition to DSLT that is conducted to manage/lower IOP. A higher proportion with the specified reduction will represent an improvement.
Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12	Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12	The number of glaucoma-related medications in use will be recorded. For medicated subjects, the Screening visit is considered baseline. For naïve (unmedicated) subjects, Visit 1 is considered baseline.

Trial Locations

Locations (2)

C-Mer Eye Clinic; 🇨🇳 Hong Kong, China

SERI; 🇸🇬 Singapore, Singapore