Health Condition 1: null- clinically significant center involved diabetic macular edema
Conditions
Interventions
Intervention1: Micropulse Yellow-577nm laser photo-stimulation
: Early Treatment Diabetic Macular Edema Study
Intervention2: Micropulse Yellow-577nm laser: Micropulse Yellow-577nm laser photo-stimula
Sponsors
LV Prasad Eye Institute
Eligibility
Inclusion criteria
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 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best Corrected Visual Acuity (BCVA) on ETDRS chart Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Central Macular Thickness (CMT) on SD-OCT ( Zeiss Cirrus) Percentage of patients gaining 5, 10, or 15 or more letters from baseline Percentage of patients losing 5, 10, or 15 or more letters from baseline Central 12º retinal sensitivity (CRS) changes on microperimetry. contrasensitivity (change from baseline) Laser induced changes discernable on fundus auto florescence Need for retreatment Any adverse collateral effect Need for retreatment Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Raja Narayanan
L V Prasad Eye Institute
Outcome results
None listed