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临床试验/CTRI/2024/11/076417
CTRI/2024/11/076417尚未招募不适用

Performance of a Generic Artificial Intelligence algorithm on a smartphone fundus camera for screening retinal conditions

Remidio Innovative Solutions Inc1 个研究点 分布在 1 个国家目标入组 545 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
545
试验地点
1
主要终点
To evaluate the performance of a generic artificial intelligence algorithm that can screen for retinal conditions/glaucoma against two reference standard (a) Ophthalmologist (specialist) diagnosis based on a comprehensive eye examination and (b) consensus image grading by two blinded specialists (adjudicated by a senior specialist).

研究概览

简要总结

Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), and Glaucoma represent formidable challenges in the field of ophthalmology, collectively constituting leading retinal causes of vision impairment and blindness globally1. Early identification of pathological changes allows for the implementation of targeted interventions, ranging from lifestyle modifications and pharmacological treatments to surgical procedures. In ophthalmology, AI has emerged as a promising ally, offering the potential to revolutionize the diagnosis and management of ocular diseases, including AMD, DR, Glaucoma, ROP, and cataract2-4

 The Medios AI, developed by Medios Technologies, Remidio Innovative Solutions in Singapore, has designed algorithms to screen referable forms of DR, AMD, and Glaucoma. This AI system has undergone extensive validation upon integration with Remidio’s non-mydriatic smartphone-based fundus camera, known as Fundus on phone (FOP). Combining and developing a unified AI algorithm (Generic AI) capable of screening for various referable retinal conditions would offer significant advantages

 This prospective study will be conducted at the general outpatient department of AEH, Pondicherry. Every consecutive patient that consents to participate will sign a written informed consent form. Following a comprehensive eye examination, fundus imaging using the study device will be captured in all the participants and the generic AI algorithm will be run on the images captured.

Methodology

All the participants will undergo a comprehensive eye examination as a part of routine eye care at the hospital. The medical record information including demographic details, best-corrected visual acuity, anterior and posterior segment examination details, goniosocopy (if Van-Herick grading 2 or less than grade 2), IOP, and other investigations (if any) conducted for final diagnosis of retinal conditions will be recorded.

The final diagnosis by the retina/glaucoma specialist along with the severity staging of the respective retinal or optic disc abnormality (if any) will be documented.

Patients evaluated in general clinic and noted to have a retinal pathology/glaucoma by examining doctor or flagged as referrable by AI will be referred to respective clinic. These patients will be evaluated by a consultant in the specialty clinic to ensure accuracy of clinical diagnosis. All the fundus images captured using reference standard fundus camera will be uploaded to a grading platform. Two specialists (one retina and one glaucoma) masked to clinical information and each other’s findings will grade (a) quality of images (disc and macula centered) captured, (b) grading of fundus images that are presented randomly.

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
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Consecutive patients above 40 years of age in the general ophthalmology clinic with known or unknown retinal conditions or glaucoma.

排除标准

  • 1.Significant media opacities (cataract worse than NO4/NC4/P3 or C3 – LOCS III scale) or other conditions precluding adequate view of the macula or disc for fundus imaging (insufficient image quality) and active infections.
  • Undergone any retinal surgery, lasers, intravitreal injections 3.Hypersensitive to light 4.Presence of any neurological conditions 5.Contraindication to dilation & without definitive diagnosis.

结局指标

主要结局

To evaluate the performance of a generic artificial intelligence algorithm that can screen for retinal conditions/glaucoma against two reference standard (a) Ophthalmologist (specialist) diagnosis based on a comprehensive eye examination and (b) consensus image grading by two blinded specialists (adjudicated by a senior specialist).

时间窗: 6 Months

次要结局

未报告次要终点

研究者

发起方
Remidio Innovative Solutions Inc
申办方类型
Other [Device Manufacturer]
责任方
Principal Investigator
主要研究者

Dr Manavi D Sindal

Aravind Eye Hospital

研究点 (1)

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