Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population (Zhuiguangzhe)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Normal Tension Glaucoma
• Intervention / Treatment: Device: External Automatic Glaucoma Laser; Procedure: Direct Selective Laser Trabeculoplasty

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • C-Mer Eye Clinic
• Singapore
  • Singapore, Singapore
    • SERI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSLT with Eagle (Group 1); Single treatment 360 degrees with laser energy of 1.2 mJ	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; Other Names: Eagle; Procedure: Direct Selective Laser Trabeculoplasty; Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure; Other Names: DSLT
Experimental: DSLT with Eagle (Group 2); Single treatment 360 degrees with laser energy of 1.8 mJ	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; Other Names: Eagle; Procedure: Direct Selective Laser Trabeculoplasty; Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure; Other Names: DSLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in IOP at 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.	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Reduction from Baseline in IOP at Month 6 and 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.	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
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	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.	Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12
Change from Baseline in Number of Glaucoma Medications at Month 6 and 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.	Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12

Collaborators and Investigators

• Sponsor: BelkinVision
• Collaborators: Singapore Eye Research Institute
• Investigators: Study Director: Dorit Raz Prag, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Glaucoma; High intraocular eye pressure; Normal tension open angle glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Optic Nerve Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Low Tension Glaucoma
• Other Study ID Numbers: #China-2022-01 (CA-PL-01-008)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No