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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406157
• Other study ID #: ZOC-MPLD
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Device:
• 577-MPL
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
• 532-SLP
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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Best Corrected Visual Acuity(BCVA)	Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol	1 year
Secondary	Change in 10°retinal sensitivity	Retinal sensitivity will be measured by microperimetry	1 year
Secondary	Change of fundus autofluorescence	Fundus autofluorescence will be evaluated for different patterns(normal, increased, and decreased)before and after treatment	1 year
Secondary	Change of Central Retinal Thickness(CRT)	Central Retinal Thickness will be performed by optical coherence tomography(OCT)	1 year

External Links

•   Randomized clinical trial evaluating modified Early Treatment Diabetic Retinopathy Study(mETDRS) versus normal or high-density micropulse photocoagulation for diabetic macular edema