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Completed

NCT Number: NCT02406157

577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema

This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema compared with 532 subthreshold laser photocoagulation.

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Key information

Conditions

Diabetic Macular Edema

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

  • To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal treatment for diabetic macular edema.
  • To investigate influence of 577nm micropulse laser photocoagulation on structure and function of macula compared with 532nm subthreshold laser photocoagulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >18 years
  • Patients with diabetes mellitus type 2
  • Diagnosed as diabetic retinopathy with Clinical Significant Macular Edema
  • Central retinal thickness(CRT) of more than 250μm as measured by optical coherence tomography (OCT)
  • ETDRS visual acuity >19 letters (Snellen equivalent of 20/400 or better)
  • No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
  • Blood glucose was controlled steadily(HbA1c≤10%)

Exclusion criteria

  • 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, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
  • Accompanied with severe opacity of refractive media that maybe impact therapy and observation
  • Accompanied with nystagmus
  • Accompanied with some history that maybe interfere with result or increase the risk of patients

Treatment and study plan

577-MPL

Device

Device for 577nm micropulse treatment of the diabetic macular edema with the following parameters:100 microns spot size,5% duty cycle of 0.2 seconds,power is tested on micropulse mode and then reduce power to 50% of visible

Other names: 577nm micropulse laser photocoagulation treatment

532-SLP

Device

Device for 532nm subthreshold treatment of the diabetic macular edema, by decomposing a subthreshold short pulse, with 10 milliseconds, 100 microns, and power(100-1000mW) adjusted according to patient's diopter transparency and pigmentation

Other names: 532nm subthreshold laser photocoagulation treatment

Primary outcomes

  1. Change of Best Corrected Visual Acuity(BCVA)

    Time frame: 1 year

    Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol

Secondary outcomes

  1. Change in 10°retinal sensitivity

    Time frame: 1 year

    Retinal sensitivity will be measured by microperimetry

  2. Change of fundus autofluorescence

    Time frame: 1 year

    Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment

  3. Change of Central Retinal Thickness(CRT)

    Time frame: 1 year

    Central Retinal Thickness will be performed by optical coherence tomography(OCT)

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Pure Yellow (577nm) Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2015
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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