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SOLX Titanium Sapphire Laser for Trabeculoplasty

Primary Purpose

Glaucoma, Glaucoma, Open Angle

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOLX Titanium Sapphire Laser (TiSaLT)
Argon Laser Trabeculoplasty (ALT)
Sponsored by
SOLX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • North Bay Eye Associates
  • International Eye Care
  • Glaucoma Associates of New York
  • Texan Eye Care
  • Mann Eye Institute
  • Credit Valley EyeCare
  • Institut du Glaucome de Montréal
  • Sourasky Medical Center
  • Sheba Medical Center
  • Hospital Clinico San Carlos de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Titanium sapphire laser treatment

Argon laser treatment

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)

Secondary Outcome Measures

Adverse event frequency

Full Information

First Posted
September 1, 2005
Last Updated
January 28, 2010
Sponsor
SOLX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00145535
Brief Title
SOLX Titanium Sapphire Laser for Trabeculoplasty
Official Title
SOLX Titanium Sapphire Laser for Trabeculoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SOLX, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open Angle
Keywords
Glaucoma, Glaucoma, open angle, Intraocular Pressure, Trabeculoplasty, laser, laser, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Titanium sapphire laser treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Argon laser treatment
Intervention Type
Device
Intervention Name(s)
SOLX Titanium Sapphire Laser (TiSaLT)
Intervention Description
Spot laser treatment, ~50 spots over 180°
Intervention Type
Device
Intervention Name(s)
Argon Laser Trabeculoplasty (ALT)
Intervention Description
Spot laser treatment, ~50 spots over 180°
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse event frequency
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan S Peterson, MS, RAC
Organizational Affiliation
The Emmes Company, LLC
Official's Role
Study Director
Facility Information:
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
International Eye Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Glaucoma Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Texan Eye Care
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Mann Eye Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Credit Valley EyeCare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada
Facility Name
Institut du Glaucome de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Hospital Clinico San Carlos de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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SOLX Titanium Sapphire Laser for Trabeculoplasty

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