SOLX Titanium Sapphire Laser for Trabeculoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145535
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : January 29, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Glaucoma, Open Angle Device: SOLX Titanium Sapphire Laser (TiSaLT) Device: Argon Laser Trabeculoplasty (ALT) Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOLX Titanium Sapphire Laser for Trabeculoplasty
Study Start Date : May 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Titanium sapphire laser treatment
Device: SOLX Titanium Sapphire Laser (TiSaLT)
Spot laser treatment, ~50 spots over 180°
Active Comparator: 2
Argon laser treatment
Device: Argon Laser Trabeculoplasty (ALT)
Spot laser treatment, ~50 spots over 180°

Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse event frequency [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145535

United States, California
North Bay Eye Associates
Petaluma, California, United States, 94954
United States, Florida
International Eye Care
Tampa, Florida, United States, 33603
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
United States, Texas
Texan Eye Care
Austin, Texas, United States, 78705
Mann Eye Institute
Houston, Texas, United States, 77002
Canada, Ontario
Credit Valley EyeCare
Mississauga, Ontario, Canada, L5L 1W8
Canada, Quebec
Institut du Glaucome de Montréal
Montréal, Quebec, Canada, H1V 1G5
Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Hospital Clinico San Carlos de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
SOLX, Inc.
Study Director: Jan S Peterson, MS, RAC The EMMES Corporation

Responsible Party: Doug Adams, SOLX, Inc. Identifier: NCT00145535     History of Changes
Other Study ID Numbers: SLX41
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: July 2009

Keywords provided by SOLX, Inc.:
Glaucoma, open angle
Intraocular Pressure
laser, surgery

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases