SOLX Titanium Sapphire Laser for Trabeculoplasty
January 28, 2010 updated by: SOLX, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L5L 1W8
- Credit Valley Eyecare
-
-
Quebec
-
Montréal, Quebec, Canada, H1V 1G5
- Institut du Glaucome de Montréal
-
-
-
-
-
Tel Aviv, Israel, 64239
- Sourasky Medical Center
-
Tel Hashomer, Israel, 52621
- Sheba Medical Center
-
-
-
-
-
Madrid, Spain, 28040
- Hospital Clínico San Carlos de Madrid
-
-
-
-
California
-
Petaluma, California, United States, 94954
- North Bay Eye Associates
-
-
Florida
-
Tampa, Florida, United States, 33603
- International Eye Care
-
-
New York
-
New York, New York, United States, 10003
- Glaucoma Associates of New York
-
-
Texas
-
Austin, Texas, United States, 78705
- Texan Eye Care
-
Houston, Texas, United States, 77002
- Mann Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- evidence of glaucoma other than open-angle glaucoma;
- severe paracentral or generalized field defect;
- any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Titanium sapphire laser treatment
|
Spot laser treatment, ~50 spots over 180°
|
|
ACTIVE_COMPARATOR: 2
Argon laser treatment
|
Spot laser treatment, ~50 spots over 180°
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intraocular Pressure (IOP)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse event frequency
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jan S Peterson, MS, RAC, The Emmes Company, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (ESTIMATE)
September 5, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 29, 2010
Last Update Submitted That Met QC Criteria
January 28, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLX41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.