Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Akhand Jyoti Eye Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis Must have a documented diagnosis of one or more of the following medical retinal diseases that are currently or expected to be treatable with anti-VEGF biologics: 1. DR This includes nonproliferative DR (NPDR- Mild Moderate and Severe), proliferative DR (PDR), vitreous hemorrhage, traction retinal detachment secondary to PDR, and diabetic macular edema (DME). 2. AMD- Any active dry or wet stage, regardless of whether the patient is newly diagnosed (treatment-na ve) or already undergoing antiVEGF therapy and regardless of whether the patient is treatment-na ve or currently receiving antiVEGF therapy. 3. RVO: CRVO or BRVO, regardless of whether the patient is treatment-na ve or currently receiving antiVEGF therapy.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the registry if they meet any of the following criteria: 1. Any subject who cannot commit to attending necessary follow-up consultations after the initial baseline assessment. 2. Patients who do not have diabetic retinopathy, or those with advanced PDR where the expected benefit from treatment is considered highly guarded (poor prognosis). 3. Presence of scarred, inactive AMD that has not required or received any treatment for the last two years. 4. Presence of scarred, non-AMD-related that has not required or received any treatment for the last two years. 5. Presence of stable CRVO or BRVO that has not required or received any treatment for the last two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishment of a Multimodal Retinal Databank: The successful creation of a structured repository containing complete baseline and longitudinal data (demographics, clinical exams, OCT/FFA imaging, and bio-samples) for enrolled patients with medical retinal conditions (DR, DME, AMD, RVO). Timepoint: a) Day 1, After confirmation of PI then subject get enrolled in the study. b) All the data will be captured in case report form and collect all the ophthalmic images and blood sample for AI, Genomics and Proteomics study integration. c) Follow up will be collected after 7 days or as per PI recommendation. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Clinical Characterization: Identification of the most prevalent stages of retinal disease & common clinical phenotypes specific to the rural Bihar population. b) Treatment Response & Efficacy: Measurement of mean change in Best-Corrected Visual Acuity (BCVA) & Central Subfield Thickness (CST) on OCT from baseline to follow-up following anti-VEGF therapy, if given or taken. c) Bio-Imaging Repository Yield: The total volume & quality of high-resolution images & peripheral blood samples successfully linked to clinical profiles for future AI & genomic analysis. d) Economic Impact: Calculation of the average direct hospital cost per patient for managing these conditions in a rural tertiary setting. Timepoint: a) Continuously during the enrollment period & finalized after completion of enrollment. b) Outcome will be assessed only in treated patients & analyzed after completion of patient follow-up. c) Outcome will be evaluated throughout the study period, with final analysis performed after enrollment completion. d) Cost analysis will be performed after data collection is completed. | — |
Countries
India
Contacts
Public ContactDr. Sumit Randhir Singh
Akhand Jyoti Eye Hospital
Outcome results
None listed