PASCAL: Safety and Complications, Experience After 1301 C... | NCT00803153

Studies
PASCAL: Safety and Complications, Experience After 1301 Consecutive Cases

NCT00803153

Sponsor

Asociación para Evitar la Ceguera en México

Status

Withdrawn

Last Update Posted

May 30, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bruch Rupture
Choroidal Detachment

Interventions

Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

undefined

Expanded Access Info

Start Date

Dec 2008Actual

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 3, 2008

First Submission Date that Met QC Criteria

Dec 4, 2008

First Posted Date

Dec 5, 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

To report the safety and incidence of adverse effects, during and after a successful photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its modified settings

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]	Procedure

Measure	Description	Time Frame
Complication rates		during treatment and follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated with PASCAL system

Exclusion Criteria:

Uncompleted file.
Loss of follow-up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients which has been treated with the pattern scan laser system between november 2007 to july 2008.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

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
D000080324	Choroidal Effusions

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D015862	Choroid Diseases
D014603	Uveal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016503	Drug Delivery Systems

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided