SOLX Titanium Sapphire Laser for Trabeculoplasty

Sponsor

SOLX, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00145535

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma, Open Angle	Device: SOLX Titanium Sapphire Laser (TiSaLT) Device: Argon Laser Trabeculoplasty (ALT)	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SOLX Titanium Sapphire Laser for Trabeculoplasty

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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°

Arm

Intervention/Treatment

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°

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [1 year]

Secondary Outcome Measures

Adverse event frequency [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Bay Eye Associates	Petaluma	California	United States	94954
2	International Eye Care	Tampa	Florida	United States	33603
3	Glaucoma Associates of New York	New York	New York	United States	10003
4	Texan Eye Care	Austin	Texas	United States	78705
5	Mann Eye Institute	Houston	Texas	United States	77002
6	Credit Valley EyeCare	Mississauga	Ontario	Canada	L5L 1W8
7	Institut du Glaucome de Montréal	Montréal	Quebec	Canada	H1V 1G5
8	Sourasky Medical Center	Tel Aviv		Israel	64239
9	Sheba Medical Center	Tel Hashomer		Israel	52621
10	Hospital Clinico San Carlos de Madrid	Madrid		Spain	28040