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PASCAL Trabeculoplasty

Primary Purpose

Open-Angle Glaucoma

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-year-old patients
Uncontrolled Open angle (Shaffer IV)
No previous surgical trabeculoplasty or glaucoma surgery

Exclusion Criteria:

Patients not willing to participate
Angle-closure glaucoma
No clear optical media

Sites / Locations

Asociación para Evitar la Ceguera en MéxicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1

Arm Description

Patients with open-angle glaucoma

Outcomes

Primary Outcome Measures

Intraocular Pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00804323

First Posted

December 5, 2008

Last Updated

December 6, 2008

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00804323

Brief Title

PASCAL Trabeculoplasty

Official Title

Semi-Automated Patterned Laser Trabeculoplasty

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Argon laser trabeculoplasty (ALT) with 100 ms pulses is an effective therapy for lowering intraocular pressure (IOP). Similar reductions in IOP have been achieved using ns (SLT) and microsecond (MLT) pulses, which produce less thermal damage to trabecular meshwork (TM). Lack of clinically visible changes may make the accurate alignment of subsequent pulses difficult. We describe a novel technique - Patterned Laser Trabeculoplasty (PLT) using the PASCAL Photocoagulator system, and its preliminary evaluation in patients with open angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Patients with open-angle glaucoma

Intervention Type

Procedure

Intervention Name(s)

Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)

Intervention Description

Pattern Scan Laser trabeculoplasty

Primary Outcome Measure Information:

Title

Intraocular Pressure

Time Frame

During follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-year-old patients Uncontrolled Open angle (Shaffer IV) No previous surgical trabeculoplasty or glaucoma surgery Exclusion Criteria: Patients not willing to participate Angle-closure glaucoma No clear optical media

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Felix Gil Carrasco, MD

Phone

525510841400

Ext

1163

glaucoma_apec@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Gil Carrasco, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociación para Evitar la Ceguera en México

City

Mexico

State/Province

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felix Gil Carrasco, MD

Phone

525510841400

Ext

1163

glaucoma_apec@hotmail.com

First Name & Middle Initial & Last Name & Degree

Mauricio Turati Acosta, MD

First Name & Middle Initial & Last Name & Degree

Adolfo Morales Gonzalez, MD

12. IPD Sharing Statement

Learn more about this trial

PASCAL Trabeculoplasty

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