Rationale
Rural Bihar faces a high burden of
vision-threatening retinal diseases—such as Diabetic Retinopathy (DR),
Age-related Macular Degeneration (AMD), and Retinal Vein Occlusions (RVO)—yet
lacks localized data to optimize early diagnosis and access to biologic treatments
(anti-VEGF). While national datasets exist, they do not capture the specific
clinical and socioeconomic realities of Bihar’s rural populations.
Establishing a single-center tertiary
registry will bridge this gap. By systematically tracking disease patterns,
treatment adherence, and costs, this project provides the essential foundation
for personalized care and future clinical trials in a resource-limited setting.
Novelty & Significance
This is the first comprehensive medical
retinal registry in Bihar. It moves beyond simple data collection by
integrating clinical outcomes with high-resolution imaging and biological
samples, creating a unique resource for hospital-specific protocols and
regional health policy.
Aims & Objectives
Aim
To establish a hospital-based clinical
registry and biobank at a tertiary eye care center in Bihar, integrating
demographic, clinical, genomic, and AI-driven data to improve management of
retinal diseases treatable with biologics.
Objectives
Primary Objective:
Structured Data Repository: Build a
comprehensive database (demographics, clinical findings, and imaging) for
patients with DR, DME, AMD, and RVO to facilitate baseline analytics and future
AI/Genomic research.
Secondary Objectives:
Epidemiological Mapping: Assess the
local disease burden to inform resource allocation and health policy.
Longitudinal Monitoring: Track visual
and anatomical changes (BCVA, OCT, FFA) over time to evaluate treatment
efficacy.
Bio-Imaging Bank: Create an integrated
repository of peripheral blood samples and ophthalmic images for future
hypothesis-generating research.
Study Site: Akhand Jyoti Eye Hospital,
Mastichak, Saran, Bihar (Tertiary Care).
Study Design: Single-center,
prospective, observational hospital-based registry.
Nature of Study: Non-interventional;
follows "Standard of Care" protocols.
Study Duration: 12 months (December
2025 – December 2026).
Sample Size: N = 1200 patients.
Eligibility Criteria
Inclusion Criteria
Participants must meet all of the
following criteria to be eligible for the registry:
Age: Must be 18 years of age or older.
Diagnosis: Documented evidence of at
least one of the following conditions (treatment-naïve or currently undergoing
therapy):
Diabetic Retinopathy (DR): All stages
of NPDR (Mild, Moderate, Severe), PDR, Vitreous Hemorrhage, Tractional Retinal
Detachment, or Diabetic Macular Edema (DME).
Age-Related Macular Degeneration (AMD): Any
active Dry or Wet (Neovascular) stage requiring monitoring or anti-VEGF
intervention.
Retinal Vein Occlusion (RVO): Central
(CRVO) or Branch (BRVO) retinal vein occlusions.
2. Exclusion Criteria
Patients will be excluded if they
meet any of the following:
Logistical Constraints: Inability or
unwillingness to commit to long-term follow-up consultations.
Poor Visual Prognosis: Advanced PDR
where the potential benefit of treatment is considered highly guarded or
futile.
Inactive/Burned-out Disease: * Scarred
or inactive AMD with no treatment history or requirement for the past two
years.
Non-AMD related scarring that has been
stable without treatment for the past two years.
Stable CRVO or BRVO showing no activity or
treatment requirement for the past two years.
Data Collection Protocol
1. Baseline Visit (Day 0)
Face-to-face interaction and comprehensive
screening.
Patient Profile: Demographics,
Anthropometrics (Height, Weight, BMI), and Vital Signs (BP).
Medical Landscape: * Comorbidities: Focused
tracking of Diabetes, Hypertension, CAD, CKD, Thyroid, and Dyslipidemia.
Medications: Documentation of all
current systemic drugs.
Patient History: * Ophthalmic: Prior
anti-VEGF injections, vitreoretinal surgeries, or laser treatments.
Lifestyle: History of tobacco and
alcohol use.
Clinical Assessment (Standard of Care): Vision
& Pressure: Near vision, BCVA, Refraction, and IOP.
Examination: Slit-lamp (Anterior
Segment) and dilated fundus examination.
Imaging: FFA and OCT. [Requirement:
Digital images must be archived on the local server for AI characterization.]
Biosampling: If laboratory tests are
ordered, a blood sample will be processed and stored at -80°C for
the Genomics Repository.
Financials: Documentation of direct
treatment expenses to evaluate the rural financial burden.
2. Follow-up Visits (7 to 90 Days)
Longitudinal tracking as per consultant
discretion.
Interval History: Updates on systemic
medications and any new ophthalmic symptoms since the baseline visit.
Clinical Review: Repeat BCVA, IOP, and
Slit-lamp evaluation.
Treatment Monitoring:
Follow-up OCT/FFA to assess
anatomical response to treatment. [Requirement: Images archived for AI
tracking.]
Details of treatment administered (e.g.,
specific anti-VEGF molecule) and next scheduled visit.
Economic Tracking: Cumulative
treatment expenses.
Statistical Analysis Plan
The data will be exported from Microsoft
Excel to SPSS Version 27 for formal analysis.
1. Descriptive Analysis
Continuous Variables: Summarized as
Mean (SD) for normally distributed data or Median (IQR) for non-normal data.
Categorical Variables: Reported as
frequencies (n) and percentages (%).
2. Inferential & Longitudinal Analysis
Baseline Associations: * Continuous: Student’s
t-test / ANOVA (Parametric) or Mann-Whitney U / Kruskal-Wallis
(Non-parametric).
Categorical: Chi-Square or Fisher’s
Exact test.
Time-Series Tracking: Generalized Estimating
Equations (GEE) will be used to analyze longitudinal changes in continuous
outcomes (e.g., BCVA/CST) across multiple follow-up intervals, accounting for
within-subject correlation.
3. Predictive Modeling
Linear & Logistic Regression: Utilized
to identify predictors of treatment response.
Reporting: Results will be presented
as beta coefficients or Odds Ratios (OR) with 95% Confidence
Intervals (CI).
Significance: All tests will be
two-tailed with a significance threshold of p < 0.05.
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Outcome Type
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Key Metric
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Definition of Success
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Primary
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Multimodal Databank
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100% completion of baseline and
longitudinal data (Clinical + Image + Bio-sample) for all enrolled patients.
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Secondary
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Clinical Characterization
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Mapping prevalent disease stages and
phenotypes specific to the rural Bihar cohort.
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Secondary
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Treatment Efficacy
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Mean change in BCVA and Central
Subfield Thickness (CST) post-anti-VEGF therapy.
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Secondary
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Bio-Imaging Yield
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Total volume of high-quality images and
blood samples successfully linked to patient IDs.
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Secondary
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Economic Impact
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Average direct hospital cost per patient
for medical retinal management.
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