A prospective comparative observational study to assess retinal layers using Aurolab’s Retinal Optical Coherence Tomography versus Heidelberg engineering OCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- 1.Image quality including clarity, signal strength, layer segmentation and diagnostic accuracy in comparison to standard OCT
研究概览
简要总结
Bottom of Form
OCT (Optical Coherence Tomography) has been an important part of clinical investigation of new treatments for retinal pathologies. It is a promising method for imaging the retina, measuring its thickness, and displaying some features of this structure. It is useful in assessing several eye diseases, including macular edema from various causes and abnormalities of the vitreoretinal interface. Aurolab’s Retinal OCT functions similar to already available OCT as a diagnostic equipment.
This study is to compare the outcomes of Aurolab’s Retinal OCT with a marketed OCT, in order to evaluate the image quality and disease diagnosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of age 18 years or above
- •Patients diagnosed DR, ARMD, CNVM, Macular edema, RD and other pathologies which can be diagnosed through OCT.
- •3.Clear ocular media (LOCS III nuclear sclerosis 2 or below Grade 2, no significant corneal opacities) and free of floaters.
- •Pupillary dilation greater than or equal to 6 mm.
- •Ability to provide informed consent and cooperate for OCT imaging.
- •Willing to undergo imaging on both devices.
排除标准
- •1.Dense cataract or media opacities (e.g., mature cataract, significant vitreous hemorrhage) that preclude quality of OCT imaging.
- •Eyes with severe corneal pathology or poor fixation (e.g., central leucoma, band keratopathy).
- •History of recent intraocular surgery within the past 6 weeks in either eye.
- •Active intraocular inflammation (e.g., uveitis) or infection (e.g., endophthalmitis).
- •Presence of severe nystagmus or neurological disorders affecting fixation.
- •Inability to comply with study procedures or follow instructions for imaging.
结局指标
主要结局
1.Image quality including clarity, signal strength, layer segmentation and diagnostic accuracy in comparison to standard OCT
时间窗: 0
2. Ease of use and safety of the device.
时间窗: 0
次要结局
未报告次要终点
研究者
Dr M Sivadharsan
Aravind Eye Hospital