NCT02956759

Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial

Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China. Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.

Detailed description

China now has the world's largest number of diabetic persons. Population studies show that only 10% of Chinese rural-dwellers with DR receive therapy. The current standard approach to treatment of DR often requires patients to return for multiple examinations over years, before they reach trial-proven criteria for treatment. This long process is ill-suited to support good compliance with care in low-resource settings. Our recent published review suggests that earlier PRP treatment, which could reduce the burden of compliance, may be clinically effective and cost effective, but the current evidence base is insufficient to make a firm recommendation.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
PROCEDURE	Pan-retinal photocoagulation laser treatment	PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.

Timeline

• Start date: 2016-10-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2016-11-07
• Last updated: 2022-05-09

Locations

1 site across 1 country: China