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Sponsored by: |
SOLX, Inc. |
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Information provided by: | SOLX, Inc. |
ClinicalTrials.gov Identifier: | NCT00145535 |
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.
Condition | Intervention | Phase |
---|---|---|
Glaucoma Glaucoma, Open Angle |
Device: SOLX Titanium Sapphire Laser (TiSaLT) Device: Argon Laser Trabeculoplasty (ALT) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SOLX Titanium Sapphire Laser for Trabeculoplasty |
Estimated Enrollment: | 120 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Titanium sapphire laser treatment
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Device: SOLX Titanium Sapphire Laser (TiSaLT)
Spot laser treatment, ~50 spots over 180°
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2: Active Comparator
Argon laser treatment
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Device: Argon Laser Trabeculoplasty (ALT)
Spot laser treatment, ~50 spots over 180°
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This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Clinical Diagnosis of Open Angle Glaucoma
Exclusion Criteria:
Patients are not eligible for enrollment if any of the following exclusion criteria are met:
Eye to be treated has any of the following:
United States, California | |
North Bay Eye Associates | |
Petaluma, California, United States, 94954 | |
United States, Florida | |
International Eye Care | |
Tampa, Florida, United States, 33603 | |
United States, New York | |
Glaucoma Associates of New York | |
New York, New York, United States, 10003 | |
United States, Texas | |
Texan Eye Care | |
Austin, Texas, United States, 78705 | |
Mann Eye Institute | |
Houston, Texas, United States, 77002 | |
Canada, Ontario | |
Credit Valley EyeCare | |
Mississauga, Ontario, Canada, L5L 1W8 | |
Canada, Quebec | |
Institut du Glaucome de Montréal | |
Montréal, Quebec, Canada, H1V 1G5 | |
Israel | |
Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Sourasky Medical Center | |
Tel Aviv, Israel, 64239 | |
Spain | |
Hospital Clinico San Carlos de Madrid | |
Madrid, Spain, 28040 |
Study Director: | Jan S Peterson, MS, RAC | The EMMES Corporation |
Responsible Party: | SOLX, Inc. ( Doug Adams ) |
Study ID Numbers: | SLX41 |
Study First Received: | September 1, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00145535 |
Health Authority: | United States: Food and Drug Administration |
Glaucoma Glaucoma, open angle Intraocular Pressure |
Trabeculoplasty laser laser, surgery |
Glaucoma Eye Diseases Glaucoma, Open-Angle Hypertension Ocular Hypertension |