Training Group, Sensitivity Clinical Trial
Official title:
Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model During Diabetic Retinopathy Screening by Non-physician Graders in Vietnam
Verified date | November 2023 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to develop a training course for screening glaucoma using fundus images obtained during diabetic retinopathy screening by non-physician graders. The study also aims to test this training course among non-physician graders in Vietnam
Status | Completed |
Enrollment | 42 |
Est. completion date | April 30, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: Inclusion Criteria of graders: - A minimum of 42 non-physician and non-optometrist graders (mostly nurses with and without ophthalmic experience) who are currently involved in the Orbis CAFÉ diabetic retinopathy screening in Vietnam. - 12 Ophthalmologists in Vietnam taking part as DR graders in the CAFÉ project (but not having taken the optic nerve grading course) shall also assess the images. Inclusion Criteria of optic nerve photos - Normal optic nerve photos of normal persons (no DR nor glaucoma) - Optic nerve photos with moderate or advanced glaucoma - The photos shall all be of gradable quality in the opinion of the investigators, though clarity may not be optimal in order to mimic real world conditions. Exclusion Criteria: - Any graders with ophthalmic or optometric background in Vietnam Optic nerve photos suggestive of other ocular diseases (not glaucoma and not diabetes and not optic nerves that potentially can lead to loss of life) |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hanoi Medical University Hospital | Hanoi |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast |
Vietnam,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the sensitivity, specificity, area under the curve (AUC) of non-physician graders before and after training on a glaucoma test course in Vietnam. | The primary outcome is to assess change before and after training in the diagnostic accuracy (sensitivity and specificity) of non-physician graders to detect glaucoma in a standard set consisting of images encountered during diabetic retinopathy screening in Vietnam, images obtained from the standard GONE collection and population-based eye studies in Northern Ireland (Northern Ireland Cohort Longitudinal Study of Ageing, NICOLA) and China (the Handan Eye Study. | 3 months | |
Secondary | Comparing the sensitivity, specificity, area under the curve (AUC) of trained non-physician graders with general ophthalmologists on a test course in Vietnam. | Performance of the non-physician graders on the standard image set after the course will be compared with that of ophthalmologists who are also active in DR grading. | 1 month |
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