Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population (Zhuiguangzhe)

BELKIN Vision

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05902871

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

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

DSLT with Eagle (Group 1)

Experimental group

Description:

Single treatment 360 degrees with laser energy of 1.2 mJ

Treatment:

Procedure: Direct Selective Laser Trabeculoplasty

Device: External Automatic Glaucoma Laser

DSLT with Eagle (Group 2)

Experimental group

Description:

Single treatment 360 degrees with laser energy of 1.8 mJ

Treatment:

Procedure: Direct Selective Laser Trabeculoplasty

Device: External Automatic Glaucoma Laser