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Active, Not Recruiting

NCT Number: NCT05902871

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Low Tension Glaucoma Normal Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C-Mer Eye Clinic, Hong Kong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Eagle

Direct Selective Laser Trabeculoplasty

Procedure

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

Other names: DSLT

Primary outcomes

  1. Mean Change from Baseline in IOP at Month 6

    Time frame: 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 outcomes

  1. Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BelkinVision

Industry

Registry information

Official study title

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

Acronym: Zhuiguangzhe

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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