sing Intelligent Retinal Camera to detect changes in the eyes, in cases of diabetes or increased fluid pressure in the eye.

Phase 3

• Conditions: Health Condition 1: null- Glaucoma, Diabetic Retinopathy

• Registration Number: CTRI/2015/02/005511
• Lead Sponsor: Australian Government Cooperative Research Centres Program

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 2800

Inclusion Criteria

Group I: Healthy participants enrolled in the study must:

be male or female aged forty years or over

give informed consent;

be willing to comply with the clinical study visit schedule as directed by the investigator;

have no anterior or posterior segment condition other than refractive error, cataract, pseudophakia or posterior capsular opacification;

have vision correctable to at least 6 by12 or better in each eye with spectacles.

no visual field defects suggestive of glaucoma on perimetry;

Group II: Participants with diabetic retinopathy (DR) enrolled must:

be male or female aged 40 years or over

give informed consent ;

be diagnosed to be Diabetic;

be willing to comply with the clinical study visit schedule as directed by the investigator;

have eyes classifiable as having no retinopathy, minimal non-proliferative DR, mild- moderate non proliferative DR, severe non-proliferative DR and proliferative DR;

have sufficient media clarity for obtaining retinal images.

Group III: Participants with glaucoma enrolled must:

be male or female aged 40 years or over

give informed consent

have glaucomatous visual field defects

have sufficient media clarity for obtaining retinal images

Exclusion Criteria

History of chronic renal failure requiring dialysis or kidney transplant;

any active ocular inflammation or infection or evidence of toxoplasmosis or cytomegalovirus or herpes infection of eye;

eyes with dilated pupil diameter less than 3mms;

In addition, participants with diabetic retinopathy must NOT have

Any ocular disease other than DR that may confound diagnosis (exudative AMD, retinal vein occlusion, uveitis, angioid streaks, central serous chorioretinopathy, histoplasmosis, macular hole, retinal detachment, pathological myopia, epiretinal membrane);

In addition, participants with glaucoma must NOT have

Eyes with field loss attributed to non-glaucoma conditions

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To acquire retinal images using Brien Holden Visionâ?¢ retinal camera for development of automated detection algorithms of diabetic retinopathy and glaucoma.Timepoint: To acquire retinal images using Brien Holden Visionâ?¢ retinal camera for development of automated detection algorithms of diabetic retinopathy and glaucoma in two years time i.e Dec 2017

Secondary Outcome Measures

Name	Time	Method
To compare agreement between diagnoses of different grades of diabetic retinopathy, diabetic macular oedema and optic nerve head structure derived using Brien Holden Visionâ?¢ retinal camera and comparative devices.Timepoint: Secondary endpoint: Agreement between Brien Holden Vision retinal camera and other instruments/techniques for diagnosis of ocular conditions