Clinical trial NCT02406157: 577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema
Official title: Pure Yellow (577nm) Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
micropulse
laser
subthreshold
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal treatment for diabetic macular edema.
2. To investigate influence of 577nm micropulse laser photocoagulation on structure and function of macula compared with 532nm subthreshold laser photocoagulation.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Best Corrected Visual Acuity(BCVA)
timeFrame: 1 year
Secondary outcomes:
measure: Change in 10°retinal sensitivity
timeFrame: 1 year
measure: Change of fundus autofluorescence
timeFrame: 1 year
measure: Change of Central Retinal Thickness(CRT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin
role: STUDY_DIRECTOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lijun Zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.