To evaluate the functional and structural changes, as well as all collateral effects, induced with micropulse laser in comparision to the standard laser and intravitreal injection in the management of patients with diabetic macular edema.Benefit of the micropulse laser will be better safety

Not Applicable

Completed

• Conditions: Health Condition 1: null- clinically significant center involved diabetic macular edema

• Registration Number: CTRI/2015/03/005628
• Lead Sponsor: V Prasad Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients (aged >=18 years) with type 1 or 2 diabetes and DME.

Decreased vision due to center-involved CS-DME and not to other causes.

Best-corrected visual acuity (BCVA) better than 20/400 (no less than 21 ETDRS letter score) and worse that 20/40 (no more than 69 ETDRS letter score)

Increased foveal thickening due to DME and not explained by any other cause.

Central macular thickness (CMT) >= 250 microns (central subfield), measured with Zeiss Cirrus OCT.

Leakage and/or microaneurysms on Fluorescein angiography (FA) in the area of retina thickening.

HbA1C <=10 % with no unstable medical status including glycemic control and blood pressure and no history of renal failure or uncontrolled hypertension.

Willingness and ability to understand and sign a written informed consent.

Willingness and ability to return for all study visits within required visits windows.

Exclusion Criteria

Marked macular ischemia or severe perifoveal inter capillary loss on FA

Marked peripheral ischemia for which panretinal photocoagulation is required or should be considered

Retinal thickening due to epiretinal membranes or vitreomacular traction

History of panretinal laser photocoagulation performed within 6 months

History of Focal/grid laser treatment that received within 4 months or injections received within 3 months

Intraocular surgery within 12 months

Preexisting ocular condition that precludes visual improvement despite resolution of the macular edema (e.g. Severe or poorly controlled glaucoma)

Unstable medical status including glycemic control and blood pressure.

Co-morbidities such as retinal vein occlusion (RVO,) age related macular degeneration (AMD), Glaucoma, Rubeosis and other retinovascular diseases.

Media opacity, which doesnâ??t allow complete ocular examination and proposed measurements.

Dilation of pupil less than 5 mm.

Any condition that might interfere with assessment of the progression of macular edema;

Hypertension under treatment, showing values of blood pressure higher than 90 mmHg (diastolic blood pressure), or > 165 mmHg (systolic blood pressure).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) on ETDRS chart <br/ ><br> <br/ ><br>Timepoint: 1 year <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change in Central Macular Thickness (CMT) on SD-OCT ( Zeiss Cirrus) <br/ ><br>Percentage of patients gaining 5, 10, or 15 or more letters from baseline <br/ ><br>Percentage of patients losing 5, 10, or 15 or more letters from baseline <br/ ><br>Central 12º retinal sensitivity (CRS) changes on microperimetry. <br/ ><br>contrasensitivity (change from baseline) <br/ ><br>Laser induced changes discernable on fundus auto florescence <br/ ><br>Need for retreatment <br/ ><br>Any adverse collateral effect <br/ ><br>Need for retreatment <br/ ><br>Timepoint: 1 year