NCT02406157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

March 11, 2015

Last Update Submit

August 14, 2018

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edemamicropulselasersubthreshold

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in 10°retinal sensitivity

    1 year

  • Change of fundus autofluorescence

    1 year

  • Change of Central Retinal Thickness(CRT)

    1 year

Study Arms (2)

577-MPL

EXPERIMENTAL

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

Device: 577-MPL

532-SLP

ACTIVE COMPARATOR

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

Device: 532-SLP

Interventions

577-MPLDEVICE

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

Also known as: 577nm micropulse laser photocoagulation treatment
577-MPL
532-SLPDEVICE

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

Also known as: 532nm subthreshold laser photocoagulation treatment
532-SLP

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related 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.

    PMID: 21345996BACKGROUND

Study Officials

  • Chenjin Jin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Lijun Zhou

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 11, 2015

First Posted

April 2, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

CN(1)