CTRI/2015/02/005511Not yet recruitingPhase 3
Retinal image acquisition with Brien Holden Visionâ?¢ retinal camera in normal eyes and eyes with diabetic retinopathy and glaucoma - IRC
Australian Government Cooperative Research Centres Program0 sites2,800 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility 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
- •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
Investigators
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