PASCAL Trabeculoplasty | NCT00804323

Studies
PASCAL Trabeculoplasty

NCT00804323

Sponsor

Asociación para Evitar la Ceguera en México

Status

Terminated

Last Update Posted

May 30, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Open-Angle Glaucoma

Interventions

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

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Undefined

Expanded Access Info

Start Date

Dec 2007Actual

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2024

Last Update Posted Date

May 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Patients with open-angle glaucoma	Procedure: Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)	Procedure	Pattern Scan Laser trabeculoplasty	Group 1

Measure	Description	Time Frame
Intraocular Pressure		During follow-up

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felix Gil Carrasco, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación para Evitar la Ceguera en México		Mexico City	Mexico City	04030	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided