Comparing Effectiveness, Safety of 2 types of Laser Treatments for Diabetic Macular Edema Not Involving the Central Area

Phase 2

• Conditions: Health Condition 1: H358- Other specified retinal disorders

• Registration Number: CTRI/2024/07/070700
• Lead Sponsor: Aravind Eye Hospital Chennai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Non-centre involving DME – defined as SRF or IRF outside the central 1 mm of fovea

2.Treatment naïve for DME

3. = 18years age

Exclusion Criteria

1.Previous Intravitreal injections

2.Proliferative diabetic retinopathy requiring concurrent PRP. (Stable PDR patients post PRP are eligible for inclusion)

3.Concurrent other ocular comorbidities like glaucoma

4.Patients with Visually significant cataract

5.Uncontrolled hypertension, uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >12%), or recent (within 3 months) cerebrovascular accident (CVA), or myocardial infarction (MI).

6.One Eyed patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing Change in macular volume and thickness between 2 groups <br/ ><br>Timepoint: 6 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Comparing Change in BCVA between 2 groups <br/ ><br>Comparing Change in Autofluorescence and Visual Field Index HFA 24-2 between 2 groups <br/ ><br>Any adverse event related to treatment <br/ ><br>Number of patients requiring rescue treatment <br/ ><br>Change in morphological characteristics <br/ ><br>Timepoint: 6 weeks, 12 weeks