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SOLX Titanium Sapphire Laser for Trabeculoplasty

This study has been completed.
Sponsor:
Information provided by:
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT00145535
First received: September 1, 2005
Last updated: January 28, 2010
Last verified: July 2009
History of Changes
  Purpose

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 Intervention Phase
Glaucoma
Glaucoma, Open Angle
 Device: SOLX Titanium Sapphire Laser (TiSaLT)
Device: Argon Laser Trabeculoplasty (ALT)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SOLX Titanium Sapphire Laser for Trabeculoplasty

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by SOLX, Inc.:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event frequency [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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°

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145535

Locations
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
Israel
Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Spain
Hospital Clinico San Carlos de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
SOLX, Inc.
Investigators
Study Director: Jan S Peterson, MS, RAC The EMMES Corporation
  More Information

No publications provided

Responsible Party: Doug Adams, SOLX, Inc.
ClinicalTrials.gov Identifier: NCT00145535     History of Changes
Other Study ID Numbers: SLX41
Study First Received: September 1, 2005
Last Updated: January 28, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013