SOLX Titanium Sapphire Laser for Trabeculoplasty

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145535

Enrollment

120

Registered

2005-09-05

Start date

2004-05-31

Completion date

2009-06-30

Last updated

2010-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Glaucoma, Open Angle

Keywords

Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery

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.

Interventions

DEVICESOLX Titanium Sapphire Laser (TiSaLT)

Spot laser treatment, \ 50 spots over 180°

DEVICEArgon Laser Trabeculoplasty (ALT)

Spot laser treatment, \ 50 spots over 180°

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Intraocular Pressure (IOP)	1 year

Secondary

Measure	Time frame
Adverse event frequency	1 year

Countries

Canada, Israel, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026