Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

NCT ID: NCT01383525

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2019-11-30

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct Selective Trabeculoplasty

Treatment by an Direct Selective Trabeculoplasty device

Group Type: EXPERIMENTAL

Direct Selective Trabeculoplasty device

Intervention Type: DEVICE

Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.

Interventions

Direct Selective Trabeculoplasty device

Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

BelkinVision

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alon Skaat, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-11-8414

Identifier Type: -

Identifier Source: org_study_id