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

Retinal image acquisition with Brien Holden Visionâ?¢ retinal camera in normal eyes and eyes with diabetic retinopathy and glaucoma - IRC

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/02/005511

Enrollment

2800

Registered

2015-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Glaucoma, Diabetic Retinopathy

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Australia, China, India

Contacts

Public ContactDr Chandrasekhar Garudadri

L V Prasad Eye Institute

gcs@lvpei.org04030612345

Outcome results