SOLX Titanium Sapphire Laser for Trabeculoplasty

NCT ID: NCT00145535

Last Updated: 2010-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

Glaucoma; Glaucoma, Open Angle

Keywords

Glaucoma; Glaucoma, open angle; Intraocular Pressure; Trabeculoplasty; laser; laser, surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Titanium sapphire laser treatment

Group Type: EXPERIMENTAL

SOLX Titanium Sapphire Laser (TiSaLT)

Intervention Type: DEVICE

Spot laser treatment, \~50 spots over 180°

2

Argon laser treatment

Group Type: ACTIVE_COMPARATOR

Argon Laser Trabeculoplasty (ALT)

Intervention Type: DEVICE

Spot laser treatment, \~50 spots over 180°

Interventions

SOLX Titanium Sapphire Laser (TiSaLT)

Spot laser treatment, \~50 spots over 180°

Intervention Type: DEVICE

Argon Laser Trabeculoplasty (ALT)

Spot laser treatment, \~50 spots over 180°

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOLX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

SOLX, Inc.

Principal Investigators

Jan S Peterson, MS, RAC

Role: STUDY_DIRECTOR

The Emmes Company, LLC

Locations

North Bay Eye Associates

Petaluma, California, United States

International Eye Care

Tampa, Florida, United States

Glaucoma Associates of New York

New York, New York, United States

Texan Eye Care

Austin, Texas, United States

Mann Eye Institute

Houston, Texas, United States

Credit Valley EyeCare

Mississauga, Ontario, Canada

Institut du Glaucome de Montréal

Montreal, Quebec, Canada

Sourasky Medical Center

Tel Aviv, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Hospital Clinico San Carlos de Madrid

Madrid, , Spain

Countries

United States; Canada; Israel; Spain

Other Identifiers

SLX41

Identifier Type: -

Identifier Source: org_study_id