NCT00145535

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2004

Longer than P75 for phase_3

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 29, 2010

Status Verified

July 1, 2009

Enrollment Period

5.1 years

First QC Date

September 1, 2005

Last Update Submit

January 28, 2010

Conditions

GlaucomaGlaucoma, Open Angle

Keywords

GlaucomaGlaucoma, open angleIntraocular PressureTrabeculoplastylaserlaser, surgery

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    1 year

Secondary Outcomes (1)

  • Adverse event frequency

    1 year

Study Arms (2)

1

EXPERIMENTAL

Titanium sapphire laser treatment

Device: SOLX Titanium Sapphire Laser (TiSaLT)

2

ACTIVE COMPARATOR

Argon laser treatment

Device: Argon Laser Trabeculoplasty (ALT)

Interventions

SOLX Titanium Sapphire Laser (TiSaLT)DEVICE

Spot laser treatment, \~50 spots over 180°

1
Argon Laser Trabeculoplasty (ALT)DEVICE

Spot laser treatment, \~50 spots over 180°

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

International Eye Care

Tampa, Florida, 33603, United States

Location

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

Texan Eye Care

Austin, Texas, 78705, United States

Location

Mann Eye Institute

Houston, Texas, 77002, United States

Location

Credit Valley EyeCare

Mississauga, Ontario, L5L 1W8, Canada

Location

Institut du Glaucome de Montréal

Montreal, Quebec, H1V 1G5, Canada

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Hospital Clinico San Carlos de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jan S Peterson, MS, RAC

    The Emmes Company, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

May 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 29, 2010

Record last verified: 2009-07

Locations

CA(2)ES(1)IL(2)US(5)