Glaucoma Clinical Trial
Official title:
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
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.
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.
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