SOLX Titanium Sapphire Laser for Trabeculoplasty

SOLX

Status and phase

Completed

Phase 3

Conditions

Glaucoma

Glaucoma, Open Angle

Treatments

Device: SOLX Titanium Sapphire Laser (TiSaLT)

Device: Argon Laser Trabeculoplasty (ALT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00145535

SLX41

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.