Completed

Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study

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What is being tested

Direct Selective Trabeculoplasty device

Device
Who is being recruted

Eye Diseases

+ Glaucoma

+ Ocular Hypertension

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorBelkinVision
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

This is a single site outpatient feasibility study assessing the safety \& efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT). Only one eye per patient is to be treated with the investigational device during the study. The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal. Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months. Patients will be followed out to 6 months.

Official TitleDirect Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
NCT01383525
Principal SponsorBelkinVision
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesGlaucomaOcular Hypertension

Criteria

7 inclusion criteria required to participate
Patient is aged 18 years or older, with 2 sighted eyes.
Eye to be treated have average IOP *22 mmHg, measured at 2 pretreatment visits.
Eye to be treated either exhibits:
poorly controlled open angle glaucoma including Pigmentary & Exfoliative Glaucoma
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10 exclusion criteria prevent from participating
evidence of glaucoma other than open-angle glaucoma;
severe para-central or generalized field defect;
Any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
Prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment by an Direct Selective Trabeculoplasty device

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center

Ramat Gan, IsraelOpen The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center in Google Maps
CompletedOne Study Center