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

NCT02956759 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Queen's University, Belfast

    collaborator OTHER
  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Nathan Congdon, PhD · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956759 on ClinicalTrials.gov