Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

Last updated: August 17, 2018
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Edema

Diabetic Macular Edema

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT03641144
NLPD-ZOC
  • Ages 18-80
  • All Genders

Study Summary

The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18 years

  • Diagnosed as diabetic retinopathy with Mild macular edema

  • BCVA≥0.5

  • No macular laser coagulation or surgery or medicine therapy of macular edema withinthe last 6 months

Exclusion

Exclusion Criteria:

  • Blood glucose was not controlled steadily(HbA1cd≥10%)

  • Accompanied with severe hypertension（BP≥180/110mmHg）

  • Taking part in other clinical trial within 3 months

  • Planning panretinal photocoagulation(PRP) within 3 months

  • Performed cataract surgery in the last 3 months

  • Accompanied with other retinal vascular disease that can lead to macular edema, forexample branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)

  • Accompanied with severe opacity of refractive media that maybe impact therapy andobservation

  • Accompanied with nystagmus

  • Accompanied with some history that maybe interfere with result or increase the risk ofpatients

Study Design

Total Participants: 80
Study Start date:
June 01, 2018
Estimated Completion Date:
December 31, 2019

Study Description

navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .

Connect with a study center

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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