PASCAL Trabeculoplasty

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00804323
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma	Procedure: Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Semi-Automated Patterned Laser Trabeculoplasty
• Study Start Date: Dec 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2008
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Patients with open-angle glaucoma	Procedure: Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA); Pattern Scan Laser trabeculoplasty

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [During follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociación para Evitar la Ceguera en México	Mexico	DF	Mexico	04030

Sponsors and Collaborators

• Asociación para Evitar la Ceguera en México

Investigators

• Principal Investigator: Felix Gil Carrasco, MD, Asociación para Evitar la Ceguera en México

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00804323
• Other Study ID Numbers: APEC-041
• First Posted: Dec 8, 2008
• Last Update Posted: Dec 9, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Glaucoma, Open-Angle

Study Results

No Results Posted as of Dec 9, 2008