Health Condition 1: H350- Background retinopathy and retinalvascular changes Health Condition 2: H358- Other specified retinal disorders
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
All India Institute of Medical Sciences AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Either gender & Age: 18 – 80 years 2.Diagnosed with treatment naïve CI-DME: (No prior treatment for DME with either of the following: intravitreal steroids, intravitreal anti-VEGFs, laser photocoagulation, vitrectomy, etc.) 3.Patients with the VA of 6/12 (20/60, 0.5) or less will be included in the study. 4.Patients with the central retinal thickening present in the cross-sectional SD-OCT of more than or equal to 320 µm in men and more than or equal to 305 µm in women (done on Heidelberg Engineering SPECTRALIS HRA+OCT, Heidelberg Engineering, Inc. 10 Forge Parkway Franklin, MA 02038) due to CI-DME will be included in the study. 5.Media clarity, pupillary dilatation and subjects’ co-operation sufficient for fundus imaging (OCT), BCVA, microperimetry, and multifocal ERG testing will be included in the study. 6.Only patients who are willing to participate in the study would be selected.
Exclusion criteria
Exclusion criteria: 1. Patients with previously treated NCI-DME, CI-DME or proliferative diabetic retinopathy (PDR), or any other type of macular edema such as edema secondary to retinal vascular occlusions (RVO), Irvine-Gass syndrome, etc. 2. Patients with other associated retinal problems such as; vascular occlusions, age related macular degeneration (AMD), myopic degeneration, etc. 3. Any other ocular condition that might affect macular edema or alter visual acuity during the study such as; vitreomacular traction (VMT), etc. 4. Patients suffering from a significant cataract. 5. Patients on anti-glaucoma medication. 6. Pregnancy and breastfeeding. 7. Any active periocular or intraocular infection / inflammation (e.g., keratitis, scleritis, uveitis). 8. Patients not willing to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlattions in the ‘visual acuity and central macular thickness’ (VA and CMT) with the changes on ‘microperimetry and multifocal electroretinogram’ (MP and mfERG).Timepoint: At baseline, 1 month, and 3 months post intravitreal injections. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Correlations in the visual acuity (VA) & central macular thickness (CMT) before & after one-, & three-months’ follow-up after loading dose & pro-re-nata (PRN) intravitreal injections bevacizumab. 2) Correlations in the microperimetry (MP) & ‘multifocal electroretinogram (mfERG) before & after one-, & three-months’ follow-up after loading dose & pro-re-nata (PRN) intravitreal injections of bevacizumab.Timepoint: At baseline, 1 month, & 3 months post intravitreal injections. | — |
Countries
India
Contacts
Public ContactSANJAY KUMAR MISHRA
All India Institute of Medical Sciences (AIIMS)
Outcome results
None listed