RecruitingNot ApplicableNCT05902871

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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


Sponsor

BelkinVision

Enrollment

45 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 21 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

Interventions

DEVICEExternal 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

PROCEDUREDirect Selective Laser Trabeculoplasty

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


Locations(2)

C-Mer Eye Clinic

Hong Kong, China

SERI

Singapore, Singapore

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NCT05902871


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