SOLX Titanium Sapphire Laser for Trabeculoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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SOLX Titanium Sapphire Laser for Trabeculoplasty

Conditions
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Glaucoma, Glaucoma, Open Angle

Intervention / Treatment
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* Device: SOLX Titanium Sapphire Laser (TiSaLT)
* Device: Argon Laser Trabeculoplasty (ALT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Titanium sapphire laser treatment | Device: SOLX Titanium Sapphire Laser (TiSaLT)<br>* Spot laser treatment,  50 spots over 180°<br>|
| Active Comparator: 2<br>Argon laser treatment | Device: Argon Laser Trabeculoplasty (ALT)<br>* Spot laser treatment,  50 spots over 180°<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event frequency |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery