Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

NCT ID: NCT00802269

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced Fluence Parameters

Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)

Group Type EXPERIMENTAL

Retinal laser photocoagulation

Intervention Type PROCEDURE

Retinal laser photocoagulation using a 532 nm laser

Traditional parameters

Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)

Group Type ACTIVE_COMPARATOR

Retinal laser photocoagulation

Intervention Type PROCEDURE

Retinal laser photocoagulation using a 532 nm laser

Interventions

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Retinal laser photocoagulation

Retinal laser photocoagulation using a 532 nm laser

Intervention Type PROCEDURE

Other Intervention Names

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Alcon Eyelite 532 (doubled frequency Nd:Yag)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar Alvarez-Verduzco, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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APEC-032

Identifier Type: -

Identifier Source: org_study_id

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