Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871 | Recruiting

• 1 other identifier: #China-2022-01 (CA-PL-01-008)
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

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).

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

Keywords

Glaucoma; High intraocular eye pressure; Normal tension open angle glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

DSLT with Eagle (Group 1)

EXPERIMENTAL

Single treatment 360 degrees with laser energy of 1.2 mJ

Device: External Automatic Glaucoma Laser; Procedure: Direct Selective Laser Trabeculoplasty

DSLT with Eagle (Group 2)

EXPERIMENTAL

Single treatment 360 degrees with laser energy of 1.8 mJ

Device: External Automatic Glaucoma Laser; Procedure: Direct Selective Laser Trabeculoplasty

Interventions

External Automatic Glaucoma Laser DEVICE

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

Also known as: Eagle

DSLT with Eagle (Group 1); DSLT with Eagle (Group 2)

Direct Selective Laser Trabeculoplasty PROCEDURE

Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure

Also known as: DSLT

DSLT with Eagle (Group 1); DSLT with Eagle (Group 2)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BelkinVision: lead

Study Sites (2)

C-Mer Eye Clinic

Hong Kong, China

COMPLETED

SERI

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Low Tension Glaucoma; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Optic Nerve Diseases

Study Officials

• Dorit Raz Prag

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 15, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); CN (1)