Comparison of the Pristine 5.0 Widefield Fundus Camera with a Reference Standard Fundus Camera in a Retina Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard.
研究概览
简要总结
This is a prospective, randomized, comparative study designed to evaluate the performance of the Pristine 5.0 Widefield Fundus Camera in comparison with a reference standard fundus camera and an ultrawide field camera in a retina clinic setting. The study will assess image quality, retinal lesion detection, and diabetic retinopathy grading based on images captured by both devices. The Pristine 5.0 camera provides high-resolution imaging with automatic focus and capture modes. Eligible participants will undergo dilated fundus photography using both devices. Two masked retina specialists will grade all images for quality and retinal pathology. Patient comfort and experience with Pristine 5.0 will be evaluated using a structured questionnaire. The study aims to determine diagnostic accuracy and agreement levels between imaging systems and clinical evaluation by ophthalmologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Every consecutive participant above 18 years of age who consents to participate in the study and visit the retina clinic.
排除标准
- •Subjects with significant media opacity that blocks a sufficient view of the fundus, such as advanced cataracts, corneal opacity, vitreous hemorrhage, or other pathology.
- •Subjects with inability to fixate on the target, such as those with nystagmus or amblyopia.
- •Subjects with active eye infection, sudden loss of vision, or who are in the immediate post-operative period (less than two weeks).
- •Subjects who are hypersensitive to light or unable to tolerate fundus imaging.
- •Subjects for whom dilation is contraindicated, such as those with angle closure glaucoma or ocular hypertension.
结局指标
主要结局
Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard.
时间窗: Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard.
次要结局
- Assessment of image quality, including factors such as illumination, focus, fixation, and presence of external artifacts, for images captured using Pristine 5.0 and the Reference Standard.(At the time of imaging (baseline visit))
- Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy detection by the Pristine 5.0 system compared to the Reference Standard.(At the time of image interpretation (within 1 week of image capture))
- Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy diagnosis by the Pristine 5.0 system and the Reference Standard compared to the ophthalmologist diagnosis.(At the time of image interpretation (within 1 week of image capture))
研究者
Dr Jay Sheth
Shantilal Shanghvi Eye Institute