Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: Intravitreal Injection: intravitreal injection therapy for diabetic macular edema.
Treatment naïve patients with DME who were advised intravitreal anti-VEGF injections.
Follow ups are b
Sponsors
L V Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Treatment naïve patients diagnosed with DME receiving intravitreal antiVEGF injections 2.Diagnosis of DME was confirmed by a retinal specialist with contact lens biomicroscopy, and OCT findings indicating clinically significant macular edema increased central retinal thickness and the presence of fluid. 3.CRT is considered increased when it is greater than 250microns on SD-OCT
Exclusion criteria
Exclusion criteria: 1.Tractional component of DME 2.Previous intraocular surgery 3.Proliferative diabetic retinopathy with vitreous haemorrhage 4.Clinically significant cataract with media haze grade = 3 5.Hearing, talking impaired adults 6.Pregnant women 7.Eyes which developed infection post treatment Patients who developed any kind of infection/reaction post treatment will be excluded from the study and will be treated accordingly and will be reported to HICC committee /Data Safety Committee of LVPEI in order to prevent such scenarios in future.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)To evaluate the macular thickness, BCVA and vessel densities with OCT/OCTA in pre and post anti-VEGF injections in pro re nata (PRN) regimen b)To compare macular threshold sensitivity in PRN radial sectors for diabetic macular edema Timepoint: Baseline, 3 and 6 months follow-up visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| c) To correlate OCTA structural changes with macular threshold sensitivity from microperimetry.Timepoint: Baseline, 3 Months, 6 months | — |
Countries
India
Contacts
Public ContactDr Padmaja Kumari Rani
LV Prasad Eye Institute
Outcome results
None listed