Performance of an automated tool for glaucoma screening that is integrated on a portable fundus camera (camera that images back of the eye)

Not Applicable

Conditions: Health Condition 1: H40-H42- Glaucoma

Registration Number: CTRI/2021/07/034873

Lead Sponsor: Remidio Innovative Solutions

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Participants older than 18 years of age who can provide a written informed consent

Exclusion Criteria

1.Participants unwilling to sign the informed consent

2.Patient with acute or sudden vision loss

3.Patient deemed to have narrow angles on gonioscopy and cannot be dilated

4.Co-existing retinal/disc pathologies precluding view of disc

5.Significant media opacity precluding adequate view of the disc

6.Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., uncontrolled intraocular pressure, active eye infection, <3months post glaucoma filtering surgery, unstable medical status including blood pressure or glycemic control etc).

7.Participant is contraindicated for imaging by fundus imaging systems used in the study:

a.Participant is hypersensitive to light

b.Participant recently underwent photodynamic therapy (PDT)

c.Participant is photosensitive or is consuming medication that causes photosensitivity.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assess the diagnostic ability in terms of sensitivity and specificity of an automated glaucoma screening tool to detect referable glaucoma against the diagnosis made by glaucoma specialistTimepoint: At baseline. Target sensitivity of 80%

Secondary Outcome Measures

Name	Time	Method
Agreement between the vertical cup-to-disc ratio measurement made by the AI, SD-OCT, automated stereo fundus camera, clinical exam and majority grading by the specialists on monoscopic imagesTimepoint: At baseline;Assess the accuracy (in terms of mean absolute error) of the automated disc measurement tool for vCDR against a predicate deviceTimepoint: At baseline;Assess the diagnostic ability (sensitivity and specificity) of an automated glaucoma screening tool to detect referable glaucoma against the glaucoma specialist making a provisional diagnosis at the end of optic disc evaluationTimepoint: At baseline;Compare agreement between monoscopic disc assessment on FOP to stereoscopic disc assessment on predicate deviceTimepoint: At baseline;Compare the image quality (in terms of sufficient quality images) between FOP and predicate device to make a diagnosis of glaucomaTimepoint: At baseline