Status:
COMPLETED
SOLX Titanium Sapphire Laser for Trabeculoplasty
Lead Sponsor:
SOLX, Inc.
Conditions:
Glaucoma
Glaucoma, Open Angle
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fail...
Detailed Description
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 glauc...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of Open Angle Glaucoma
- Patient is aged 18 years or older, with 2 sighted eyes.
- Eye to be treated have average IOP greater or equal to 22 mmHg, measured at 2 pretreatment visits.
- Eye to be treated either exhibits:
- poorly controlled open angle glaucoma and on maximal tolerated medical therapy
- OR poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous ALT; can treat over previous SLT)
Exclusion
- Patients are not eligible for enrollment if any of the following exclusion criteria are met:
- Eye to be treated has any of the following:
- evidence of glaucoma other than open-angle glaucoma;
- severe paracentral 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 TiSaLT.
- Having concurrent treatment with systemic steroids.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00145535
Start Date
May 1 2004
End Date
June 1 2009
Last Update
January 29 2010
Active Locations (10)
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1
North Bay Eye Associates
Petaluma, California, United States, 94954
2
International Eye Care
Tampa, Florida, United States, 33603
3
Glaucoma Associates of New York
New York, New York, United States, 10003
4
Texan Eye Care
Austin, Texas, United States, 78705