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  Device: Argon Laser Trabeculoplasty (ALT)	Phase III

Further Study Details: 

Primary Outcomes: Intraocular Pressure (IOP)
Secondary Outcomes: Adverse event frequency
Expected Total Enrollment:  120

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: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

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:

1. evidence of glaucoma other than open-angle glaucoma;
2. severe paracentral or generalized field defect;
3. any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
4. 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.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00145535

Doug Adams      617-353-1277    doug@solx.com

New York
      Glaucoma Associates of New York, New York,  New York,  10003,  United States; Recruiting
Texas
      Texan Eye Care, Austin,  Texas,  78705,  United States; Recruiting
      Mann Eye Institute, Houston,  Texas,  77002,  United States; Recruiting
Israel
      Sheba Medical Center, Tel Hashomer,  52621,  Israel; No longer recruiting
Spain
      Hospital Clinico San Carlos de Madrid, Madrid,  28040,  Spain; Recruiting

Study ID Numbers:  SLX41
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145535
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06