Oculomics: Developing a Tertiary-Care Databank of Common Retinal Conditions with Integrated Genomic, Proteomic, and AI-Based Characterization in the Rural Settings of Bihar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
研究概览
简要总结
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.
- 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
- 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.
- 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.
- 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 (%).
- 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.
- 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.
| Outcome Type |
Key Metric
Definition of Success
|Primary
Multimodal Databank
100% completion of baseline and longitudinal data (Clinical + Image + Bio-sample) for all enrolled patients.
|Secondary
Clinical Characterization
Mapping prevalent disease stages and phenotypes specific to the rural Bihar cohort.
|Secondary
Treatment Efficacy
Mean change in BCVA and Central Subfield Thickness (CST) post-anti-VEGF therapy.
|Secondary
Bio-Imaging Yield
Total volume of high-quality images and blood samples successfully linked to patient IDs.
|Secondary
Economic Impact
Average direct hospital cost per patient for medical retinal management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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:
- •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).
- •AMD- Any active dry or wet stage, regardless of whether the patient is newly diagnosed (treatment-naïve) or already undergoing antiVEGF therapy and regardless of whether the patient is treatment-naïve or currently receiving antiVEGF therapy.
- •RVO: CRVO or BRVO, regardless of whether the patient is treatment-naïve or currently receiving antiVEGF therapy.
排除标准
- •Patients will be excluded from the registry if they meet any of the following criteria:
- •Any subject who cannot commit to attending necessary follow-up consultations after the initial baseline assessment.
- •Patients who do not have diabetic retinopathy, or those with advanced PDR where the expected benefit from treatment is considered highly guarded (poor prognosis).
- •Presence of scarred, inactive AMD that has not required or received any treatment for the last two years.
- •Presence of scarred, non-AMD-related that has not required or received any treatment for the last two years.
- •Presence of stable CRVO or BRVO that has not required or received any treatment for the last two years.
研究者
Dr. Ajit Kumar Poddar
Akhand Jyoti Eye Hospital