Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model During Diabetic Retinopathy Screening by Non-physician Graders in Vietnam
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|ClinicalTrials.gov Identifier: NCT05151757|
Recruitment Status : Recruiting
First Posted : December 9, 2021
Last Update Posted : December 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Training Group, Sensitivity||Other: A standard image training set||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a before and after study in which non physician graders will undergo testing on the standard image set at baseline, and then complete a training course. They will then undergo a post course test on the standard image set. Their performance in the post course will be compared to baseline performance.|
|Masking:||None (Open Label)|
|Official Title:||Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model During Diabetic Retinopathy Screening by Non-physician Graders in Vietnam|
|Actual Study Start Date :||November 22, 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: To test the effectiveness of a training course to improve graders ability to detect glaucoma
Study design: This is an uncontrolled interventional experimental before and after study in which a minimum of 42 non-physician graders shall be trained to screen for glaucoma using optic nerve photos obtained for diabetic retinopathy (DR) screening in Vietnam.
The standard image training set will consist of about 50 normal optic nerve images of people without glaucoma and about 50 images of people with glaucoma, obtained from the on-going ORBIS CAFÉ DR screening programme (in which the graders are working), population-based eye studies in the UK (NICOLA) and the standard Glaucomatous Optic Neuropathy Evaluation (GONE) set of images. (https://gone-project.com/newgone/). The test set contains 60 normal and glaucomatous optic disc images.
Other: A standard image training set
The standard image training set will consist of about 50 normal optic nerve images of people without glaucoma and about 50 images of people with glaucoma. Training is done in 3 modules.
- Developing and testing a low cost opportunistic glaucoma screening model during diabetic retinopathy screening by non-physician graders in Vietnam. [ Time Frame: 3 months ]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.
- Comparing the test outcomes of trained non physician graders on the course with general ophthalmologists involved in diabetic retinopathy grading in Vietnam. [ Time Frame: 1 month ]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.
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|Ages Eligible for Study:||20 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05151757
|Contact: Nathan Congdon, MD, MPH||02890976350 ext email@example.com|
|Contact: Olusola Olawoye, MDfirstname.lastname@example.org|
|Hanoi Medical University Hospital||Recruiting|
|Contact: Nathan Congdon, MD, MPH 02890976350 ext 8929 email@example.com|
|Contact: Smit Gade +7023679633 firstname.lastname@example.org|
|Principal Investigator:||Nathan Congdon, MD MPH||Queens University Belfast|
|Responsible Party:||Nathan Congdon, Professor, Queen's University, Belfast|
|Other Study ID Numbers:||
|First Posted:||December 9, 2021 Key Record Dates|
|Last Update Posted:||December 9, 2021|
|Last Verified:||December 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||We shall share the study protocol, Statistical analysis plan and the informed consent|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||3 years after the conclusion of the study|
|Access Criteria:||Reasonable request|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Non physician graders
Endocrine System Diseases