Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma (DSLT)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
No masking for treatment. The primary endpoint assessment- intra-ocular pressure (IOP) measurement is performed by masked ophthalmologistPrimary Purpose: Treatment
|Official Title:||Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study|
- Reduction of Intra-Ocular pressure [ Time Frame: 1,3 month ]Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
- Reduction of Intra-Ocular pressure [ Time Frame: 6 months ]Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
- Number of medications [ Time Frame: 6 months ]Number of medications after treatment, as compared to before treatment.
- Physician perception of the usability of the system. [ Time Frame: 1 month ]Physician perception of the usability of the system.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Experimental: Direct Selective Trabeculoplasty
Treatment by an Automated Direct Selective Trabeculoplasty device
Device: Automated 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.
This is a single site outpatient 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).
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 less than one-second, through the sclera.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383525
|The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center|
|Ramat-Gan, Israel, 52621|
|Principal Investigator:||Alon Skaat, MD||Sheba Medical Center|