Standardization of Optical Coherence Tomography Angiography Biomarkers for Early Diabetic Retinopathy Correlation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- • Establishment of OCTA biomarker thresholds predictive of early diabetic retinopathy (DR).
研究概览
简要总结
This study aims to evaluate the role of Optical Coherence Tomography Angiography in the early detection of diabetic retinopathy by identifying and standardizing retinal microvascular biomarkers. Diabetic retinopathy is a major cause of preventable vision loss, and early diagnosis before the appearance of clinical signs is critical for timely intervention.
The study will be a prospective cross sectional observational study involving type 2 diabetic patients with no or mild to moderate non proliferative diabetic retinopathy and age matched non diabetic controls. OCTA will be used to assess key biomarkers such as vessel density, foveal avascular zone area, perfusion density, and other microvascular and structural retinal parameters. These findings will be correlated with systemic diabetic control markers including HbA1c and functional visual outcomes such as best corrected visual acuity and contrast sensitivity.
The diagnostic performance of OCTA will be compared with conventional imaging techniques like fundus photography and fluorescein angiography. Statistical analysis will be used to establish standardized threshold values for OCTA biomarkers that can reliably differentiate early diabetic retinopathy from normal retinal findings.
The expected outcome is to validate OCTA as a sensitive and non invasive tool for early detection and monitoring of diabetic retinopathy, enabling earlier diagnosis, better risk stratification, and improved personalized management for patients at risk of diabetic vision loss.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Type 2 diabetic patients with or without clinically diagnosed DR.
- •Non-diabetic control subjects of similar age for baseline OCTA biomarker comparisons.
- •Clear ocular media allowing high-quality OCTA imaging.
- •Informed consent to participate in the study.
排除标准
- •Retinal diseases such as age-related macular degeneration AMD, retinitis pigmentosa RP, retinal vein occlusion RVO, or central serous retinopathy CSR.
- •Recent intraocular surgeries less than 6 months or trauma.
- •Ocular media opacities like dense cataracts causing poor imaging quality.
结局指标
主要结局
• Establishment of OCTA biomarker thresholds predictive of early diabetic retinopathy (DR).
时间窗: Single assessment at baseline.
• Measurement: Quantitative analysis of vessel density, foveal avascular zone (FAZ) area, and perfusion density using OCTA.
时间窗: Single assessment at baseline.
次要结局
- • Correlation of OCTA biomarkers with systemic and visual parameters, including HbA1c, best-corrected visual acuity (BCVA), Contrast, and duration of diabetes.(• Comparison of the diagnostic accuracy of OCTA with fundus photography and fluorescein angiography (FA).)
研究者
Brajesh Kumar
Dr. Shroffs Charity Eye Hospital
