Pain Using Reduced Fluence Parameters in Photocoagulation... | NCT00802269

Studies
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

NCT00802269

Sponsor

Asociación para Evitar la Ceguera en México

Status

Terminated

Last Update Posted

May 30, 2024Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

Proliferative Diabetic Retinopathy

Interventions

Retinal laser photocoagulation

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

Mar 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Dec 3, 2008

First Submission Date that Met QC Criteria

Dec 3, 2008

First Posted Date

Dec 4, 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)

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

The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reduced Fluence Parameters	Experimental	Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)	Procedure: Retinal laser photocoagulation
Traditional parameters	Active Comparator	Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)	Procedure: Retinal laser photocoagulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retinal laser photocoagulation	Procedure	Retinal laser photocoagulation using a 532 nm laser	Reduced Fluence Parameters Traditional parameters

Measure	Description	Time Frame
Pain (NRS-11 scale)		Immediately post-treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years or older, that signed informed consent
Proliferative diabetic retinopathy with indication for panretinal photocoagulation

Exclusion Criteria:

Previous retinal photocoagulation
Previous ocular surgical procedures
Ocular media opacities
History of trigeminal neuralgia
Chronic ocular pain
Depression under conductual or medical treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Oscar Alvarez-Verduzco, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided