Clinical trial NCT00145535: SOLX Titanium Sapphire Laser for Trabeculoplasty
Official title: SOLX Titanium Sapphire Laser for Trabeculoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Glaucoma, Open Angle
Keywords: Glaucoma
Glaucoma, open angle
Intraocular Pressure
Trabeculoplasty
laser
laser, surgery
Lead sponsor: SOLX, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 1 year
Secondary outcomes:
measure: Adverse event frequency
timeFrame: 1 year
Other outcomes:
Locations:
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Tampa
country: United States
facility: International Eye Care
state: Florida
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
city: Austin
country: United States
facility: Texan Eye Care
state: Texas
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
city: Mississauga
country: Canada
facility: Credit Valley EyeCare
state: Ontario
city: Montréal
country: Canada
facility: Institut du Glaucome de Montréal
state: Quebec
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos de Madrid
Study officials:
affiliation: The Emmes Company, LLC
name: Jan S Peterson, MS, RAC
role: STUDY_DIRECTOR
References: