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Safety and Efficacy of Low-Fluence PRP for PDR

NCT01737957 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-30

No results posted yet for this study

Summary

To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

DEVICE

Low-fluence PRP with 532nm green LASER

To administer low-fluence PRP in a single session for PDR

DEVICE

Full-Fluence PRP with 532nm LASER

To administer full-fluence PRP in two sessions for PDR

Sponsors & Collaborators

  • Asociación para Evitar la Ceguera en México

    lead OTHER

Principal Investigators

  • Guillermo Salcedo-Villanueva, MD · Asociación para Evitar la Ceguera en México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737957 on ClinicalTrials.gov