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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Micropulse 577 nm Laser Photocoagulation Versus Conventional 532 nm Laser Photocoagulation for Diabetic Macular Oedema

NCT01045239

Diabetic Macular Edema

UNKNOWN PHASE2

Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

NCT03641144

Diabetic Macular Edema

UNKNOWN NA

Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy

NCT01044875

Proliferative Diabetic Retinopathy

UNKNOWN NA

Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema

NCT05759884

Macular Edema Due to Type 2 Diabetes Mellitus

UNKNOWN NA

Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

NCT04359771

Diabetic Retinopathy Macula Edema

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

577-MPL

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

Group Type EXPERIMENTAL

577-MPL

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

532-SLP

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

577nm micropulse laser photocoagulation treatment 532nm subthreshold laser photocoagulation treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No