SOLX Titanium Sapphire Laser for Trabeculoplasty

Phase 3

Completed

• Conditions: Glaucoma; Glaucoma, Open Angle
• Interventions: Device: SOLX Titanium Sapphire Laser (TiSaLT); Device: Argon Laser Trabeculoplasty (ALT)

• Registration Number: NCT00145535
• Lead Sponsor: SOLX, Inc.

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 failed laser trabeculoplasty.

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 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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2010-01-28
• Last Update Posted: 2010-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SOLX Titanium Sapphire Laser (TiSaLT)	Titanium sapphire laser treatment
2	Argon Laser Trabeculoplasty (ALT)	Argon laser treatment

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse event frequency	1 year

Trial Locations

Locations (10)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Glaucoma Associates of New York; 🇺🇸 New York, New York, United States

International Eye Care; 🇺🇸 Tampa, Florida, United States

Mann Eye Institute; 🇺🇸 Houston, Texas, United States

Institut du Glaucome de Montréal; 🇨🇦 Montréal, Quebec, Canada

Credit Valley EyeCare; 🇨🇦 Mississauga, Ontario, Canada

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Hospital Clinico San Carlos de Madrid; 🇪🇸 Madrid, Spain

Texan Eye Care; 🇺🇸 Austin, Texas, United States