SOLX Titanium Sapphire Laser for Trabeculoplasty

Glaucoma Clinical Trial

Official title:

SOLX Titanium Sapphire Laser for Trabeculoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145535
• Other study ID #: SLX41
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: January 28, 2010
• Start date: May 2004
• Est. completion date: June 2009

Study information

• 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

Clinical Trial 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 failed laser trabeculoplasty.

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 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle
• Glaucoma, Open-Angle

Intervention

Device:
• SOLX Titanium Sapphire Laser (TiSaLT)
Spot laser treatment, ~50 spots over 180°
• Argon Laser Trabeculoplasty (ALT)
Spot laser treatment, ~50 spots over 180°

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SOLX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)		1 year	No
Secondary	Adverse event frequency		1 year	Yes