Safety and Efficacy of Low-Fluence PRP for PDR

Asociación para Evitar la Ceguera en México60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Proliferative Diabetic Retinopathy

Interventions

Low-fluence PRP with 532nm green LASERDEVICE

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

Full-Fluence PRP with 532nm LASERDEVICE

To administer full-fluence PRP in two sessions for PDR

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetics * Proliferative diabetic retinopathy Exclusion Criteria: * Previous treatment with PRP * Media opacities * Previous treatment for macular edema (LASER or intravitreal injections) * Recent (less than 6 months) ophthalmic surgery * Only eyes * Intra-retinal or sub-retinal fluid with foveal involvement * Chronic renal failure * History of liver or pancreatic transplant

Locations (1)

Asociación Para Evitar la Ceguera en México

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Macular thickness change

Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)

Time frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Secondary Outcomes

Adverse events

Presence or absence of adverse events

Time frame: 16 weeks

Data from ClinicalTrials.gov

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