Safety and Efficacy of Low-Fluence PRP for PDR

Not Applicable

Terminated

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Device: Full-Fluence PRP with 532nm LASER; Device: Low-fluence PRP with 532nm green LASER

• Registration Number: NCT01737957
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full-fluence	Full-Fluence PRP with 532nm LASER	Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy
Low-fluence	Low-fluence PRP with 532nm green LASER	Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy

Primary Outcome Measures

Name	Time	Method
Macular thickness change	Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks	Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
Adverse events	16 weeks	Presence or absence of adverse events

Trial Locations

Locations (1)

Asociación Para Evitar la Ceguera en México; 🇲🇽 Mexico City, DF, Mexico