Health Condition 1: H358- Other specified retinal disorders
Conditions
Interventions
Intervention1: 577 nm subthreshold micropulse laser (SMPL): Iridex 577 nm, Spot size: 150-200 micron, no spacing , 200ms pulse, 5% cycle, 50% of threshold power
Control Intervention1: 532nm modified
Sponsors
Aravind Eye Hospital Chennai
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing Change in macular volume and thickness between 2 groups Timepoint: 6 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparing Change in BCVA between 2 groups Comparing Change in Autofluorescence and Visual Field Index HFA 24-2 between 2 groups Any adverse event related to treatment Number of patients requiring rescue treatment Change in morphological characteristics Timepoint: 6 weeks, 12 weeks | — |
Countries
India
Contacts
Public ContactDr Puja Maitra
Vitreoretinal Department, Aravind Eye Hospital, Chennai
Outcome results
None listed