Glaucoma Clinical Trial
Official title:
SOLX Titanium Sapphire Laser for Trabeculoplasty
Verified date | July 2009 |
Source | SOLX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 (180° available to treat if previous ALT; can treat over previous SLT) 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Credit Valley EyeCare | Mississauga | Ontario |
Canada | Institut du Glaucome de Montréal | Montréal | Quebec |
Israel | Sourasky Medical Center | Tel Aviv | |
Israel | Sheba Medical Center | Tel Hashomer | |
Spain | Hospital Clinico San Carlos de Madrid | Madrid | |
United States | Texan Eye Care | Austin | Texas |
United States | Mann Eye Institute | Houston | Texas |
United States | Glaucoma Associates of New York | New York | New York |
United States | North Bay Eye Associates | Petaluma | California |
United States | International Eye Care | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
SOLX, Inc. |
United States, Canada, Israel, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular Pressure (IOP) | 1 year | No | |
Secondary | Adverse event frequency | 1 year | Yes |
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