Safety and Efficacy of Low-Fluence PRP for PDR

Asociación para Evitar la Ceguera en México

Status: Terminated

Conditions: Proliferative Diabetic Retinopathy

Treatments: Device: Low-fluence PRP with 532nm green LASER; Device: Full-Fluence PRP with 532nm LASER

Study type: Interventional

Funder types: Other

Identifiers

NCT01737957

APEC-LFPRP

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Low-fluence

Experimental group

Description:

Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy

Treatment:

Device: Low-fluence PRP with 532nm green LASER

Full-fluence

Active Comparator group

Description:

Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy

Treatment:

Device: Full-Fluence PRP with 532nm LASER