NCT01383525

Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: BelkinVision · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2019-08-01
• Completion: 2019-11-01
• First posted: 2011-06-28
• Last updated: 2020-02-26

Locations

1 site across 1 country: Israel