Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model During Diabetic Retinopathy Screening by Non-physician Graders in Vietnam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Queen's University, Belfast
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Comparing the sensitivity, specificity, area under the curve (AUC) of non-physician graders before and after training on a glaucoma test course in Vietnam.
Study Overview
Brief Summary
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
Detailed Description
Background:
According to the International Diabetes Federation (IDF), the prevalence of diabetes will increase by 51% from 463 million in 2019 to 743 million in 2045 among adults between the ages of 20-79 years. This increase is projected to be 15% in Europe, 33% in North America, 74% in South East Asia and 143% in Africa from 2019 to 2045. About 3 in 5 participants who have diabetes in Africa remain undiagnosed. Whereas the total diabetes related health expenditure is 494 billion USD in high income countries, and 264 billion USD in middle income countries, low income countries expend only 1 billion USD. Therefore, diabetes is a huge problem worldwide especially in low income countries.
Diabetic retinopathy is the most common microvascular complication of diabetes which leads to blindness if left untreated. Diabetic retinopathy is one of the leading causes of blindness especially among the working group when vision is very important for daily living. Diabetic retinopathy is identified in a third of diabetic patients.
Diabetic retinopathy (DR) however can be treated effectively but early detection and timely referrals are essential for successful outcomes. Early diagnosis, timely referrals and access to treatment through a comprehensive and systematic surveillance of the diabetic population has been shown to be clinically effective and cost effective. The United Kingdom (UK) has a national population based diabetic retinopathy screening programme which has been very successful. These screening programmes are non-existent or inadequately developed in many resource constrained settings. A study was recently concluded in Vietnam in which non-physician graders were trained to screen for diabetic retinopathy among the population of diabetic patients. The study also assessed the accuracy of DR grading among medical graders versus non-physician graders in Vietnam.
The aim of this current study is to develop and test a low cost opportunistic glaucoma screening model during diabetic retinopathy screening using the same non physician graders currently used in the recently concluded diabetic retinopathy (DR) study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: A standard image training set (Other)
Outcomes
Primary Outcomes
Comparing the sensitivity, specificity, area under the curve (AUC) of non-physician graders before and after training on a glaucoma test course 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.
Secondary Outcomes
- Comparing the sensitivity, specificity, area under the curve (AUC) of trained non-physician graders with general ophthalmologists on a test course in Vietnam.(1 month)
Investigators
Nathan Congdon
Professor
Queen's University, Belfast