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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
577-MPL
532-SLP
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring diabetic macular edema, micropulse, laser, subthreshold

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

577-MPL

532-SLP

Arm Description

577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern

532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in 10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment
Change of Central Retinal Thickness(CRT)
Central Retinal Thickness will be performed by optical coherence tomography(OCT)

Full Information

First Posted
March 11, 2015
Last Updated
August 14, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02406157
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
diabetic macular edema, micropulse, laser, subthreshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
577-MPL
Arm Type
Experimental
Arm Description
577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern
Arm Title
532-SLP
Arm Type
Active Comparator
Arm Description
532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern
Intervention Type
Device
Intervention Name(s)
577-MPL
Other Intervention Name(s)
577nm micropulse laser photocoagulation treatment
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
532-SLP
Other Intervention Name(s)
532nm subthreshold laser photocoagulation treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of Best Corrected Visual Acuity(BCVA)
Description
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in 10°retinal sensitivity
Description
Retinal sensitivity will be measured by microperimetry
Time Frame
1 year
Title
Change of fundus autofluorescence
Description
Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment
Time Frame
1 year
Title
Change of Central Retinal Thickness(CRT)
Description
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lijun Zhou
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21345996
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.
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577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema

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