Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Direct Selective Trabeculoplasty device

• Registration Number: NCT01383525
• Lead Sponsor: BelkinVision

Brief Summary

The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-26
• Study First Posted: 2011-06-28
• Study Start: 2011-07
• Primary Completion: 2019-08
• Study Completion: 2019-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-23
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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
• Patient would be considered eligible for conventional laser trabeculoplasty.
• Patient is willing to participate in the 6-month study and to adhere to the follow-up schedule.
• Patient is willing to review and sign a consent form.

Exclusion Criteria

• 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.
• Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
• Patient is pregnant.
• Patient might require other ocular surgery within the 6-month follow-up period.
• Patient has a medical history that suggested the potential for complications from Direct Selective Trabeculoplasty (DSLT)
• Having concurrent treatment with systemic steroids.
• Patient is under 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct Selective Trabeculoplasty	Direct Selective Trabeculoplasty device	Treatment by an Direct Selective Trabeculoplasty device

Primary Outcome Measures

Name	Time	Method
Reduction of Intra-Ocular pressure	1,3 month	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment

Secondary Outcome Measures

Name	Time	Method
Reduction of Intra-Ocular pressure	6 months	Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment

Trial Locations

Locations (1)

The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center; 🇮🇱 Ramat-Gan, Israel