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AzTrials

Diabetic Macular EdemaNCT02406157

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

A study testing 577-MPL and 532-SLP in people with Diabetic Macular Edema, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
577-MPL and 532-SLP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
Jan 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

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.

Read the 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.
Being tested
577-MPL, 532-SLP
Keywords
diabetic macular edema, micropulse, laser, subthreshold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 577-MPLDevice

    Also called 577nm micropulse laser photocoagulation treatment

    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-SLPDevice

    Also called 532nm subthreshold laser photocoagulation treatment

    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

Study groups in NCT02406157
Study groupRoleWhat they receive
577-MPLExperimental577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern
Receives: Device: 577-MPL
532-SLPActive comparator532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern
Receives: Device: 532-SLP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Best Corrected Visual Acuity(BCVA)

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

    Measured: 1 year

Secondary outcomes (3)

  1. Change in 10°retinal sensitivity

    Retinal sensitivity will be measured by microperimetry

    Measured: 1 year

  2. Change of fundus autofluorescence

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

    Measured: 1 year

  3. Change of Central Retinal Thickness(CRT)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406157
Sponsor's protocol ID
ZOC-MPLD
Status last verified
Aug 2018
First submitted
11 Mar 2015
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21345996

Questions about this trial

What is this clinical trial studying?

A study testing 577-MPL and 532-SLP in people with Diabetic Macular Edema, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Best Corrected Visual Acuity(BCVA) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406157, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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