Safety and Efficacy of Low-Fluence PRP for PDR
Not Applicable
Terminated
- Conditions
- Proliferative Diabetic Retinopathy
- 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
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
- 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
Asociación Para Evitar la Ceguera en México🇲🇽Mexico City, DF, Mexico