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Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT ID: NCT05902871

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-03-31

Brief Summary

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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

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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

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Primary Open Angle Glaucoma Ocular Hypertension Normal Tension Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSLT with Eagle (Group 1)

Single treatment 360 degrees with laser energy of 1.2 mJ

Group Type EXPERIMENTAL

Direct Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

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

External Automatic Glaucoma Laser

Intervention Type 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

DSLT with Eagle (Group 2)

Single treatment 360 degrees with laser energy of 1.8 mJ

Group Type EXPERIMENTAL

Direct Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

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

External Automatic Glaucoma Laser

Intervention Type 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

Interventions

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Direct Selective Laser Trabeculoplasty

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

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Other Intervention Names

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Eagle DSLT

Eligibility Criteria

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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.

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BelkinVision

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorit Raz Prag

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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C-Mer Eye Clinic

Hong Kong, , China

Site Status COMPLETED

SERI

Singapore, , Singapore

Site Status RECRUITING

Countries

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China Singapore

Facility Contacts

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Clinical Trial Lead

Role: primary

[email protected]

Other Identifiers

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#China-2022-01 (CA-PL-01-008)

Identifier Type: -

Identifier Source: org_study_id