Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

BELKIN Vision

Status

Completed

Conditions

Glaucoma

Treatments

Device: Direct Selective Trabeculoplasty device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01383525

SHEBA-11-8414

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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