Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model by Non-physician Graders in Vietnam

NCT05151757 | Completed

• 1 other identifier: MHLS 20_98
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Training Group, Sensitivity

Keywords

Screening; Glaucoma; Non physician graders; Fundus images

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

To test the effectiveness of a training course to improve graders ability to detect glaucoma

EXPERIMENTAL

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

Interventions

A standard image training set OTHER

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.

To test the effectiveness of a training course to improve graders ability to detect glaucoma

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Hanoi Medical University Hospital

Hanoi, Vietnam

Location

Related Publications (19)

• International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: 2019. Available at: https://www.diabetesatlas.org. https://www.diabetesatlas.org/.

  BACKGROUND

• Sivaprasad S, Gupta B, Crosby-Nwaobi R, Evans J. Prevalence of diabetic retinopathy in various ethnic groups: a worldwide perspective. Surv Ophthalmol. 2012 Jul-Aug;57(4):347-70. doi: 10.1016/j.survophthal.2012.01.004. Epub 2012 Apr 28.

  PMID: 22542913 BACKGROUND

• Liew G, Michaelides M, Bunce C. A comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), 1999-2000 with 2009-2010. BMJ Open. 2014 Feb 12;4(2):e004015. doi: 10.1136/bmjopen-2013-004015.

  PMID: 24525390 BACKGROUND

• Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.

  PMID: 20580421 BACKGROUND

• Sharp PF, Olson J, Strachan F, Hipwell J, Ludbrook A, O'Donnell M, Wallace S, Goatman K, Grant A, Waugh N, McHardy K, Forrester JV. The value of digital imaging in diabetic retinopathy. Health Technol Assess. 2003;7(30):1-119. doi: 10.3310/hta7300.

  PMID: 14604499 BACKGROUND

• Jones S, Edwards RT. Diabetic retinopathy screening: a systematic review of the economic evidence. Diabet Med. 2010 Mar;27(3):249-56. doi: 10.1111/j.1464-5491.2009.02870.x.

  PMID: 20536486 BACKGROUND

• Bathija R, Gupta N, Zangwill L, Weinreb RN. Changing definition of glaucoma. J Glaucoma. 1998 Jun;7(3):165-9.

  PMID: 9627855 BACKGROUND

• Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.

  PMID: 28577860 BACKGROUND

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

  PMID: 16488940 BACKGROUND

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

  PMID: 24974815 BACKGROUND

• Ramakrishnan R, Nirmalan PK, Krishnadas R, Thulasiraj RD, Tielsch JM, Katz J, Friedman DS, Robin AL. Glaucoma in a rural population of southern India: the Aravind comprehensive eye survey. Ophthalmology. 2003 Aug;110(8):1484-90. doi: 10.1016/S0161-6420(03)00564-5.

  PMID: 12917161 BACKGROUND

• Dandona L, Dandona R, Srinivas M, Mandal P, John RK, McCarty CA, Rao GN. Open-angle glaucoma in an urban population in southern India: the Andhra Pradesh eye disease study. Ophthalmology. 2000 Sep;107(9):1702-9. doi: 10.1016/s0161-6420(00)00275-x.

  PMID: 10964833 BACKGROUND

• Shaikh Y, Yu F, Coleman AL. Burden of undetected and untreated glaucoma in the United States. Am J Ophthalmol. 2014 Dec;158(6):1121-1129.e1. doi: 10.1016/j.ajo.2014.08.023. Epub 2014 Aug 22.

  PMID: 25152501 BACKGROUND

• Hennis A, Wu SY, Nemesure B, Honkanen R, Leske MC; Barbados Eye Studies Group. Awareness of incident open-angle glaucoma in a population study: the Barbados Eye Studies. Ophthalmology. 2007 Oct;114(10):1816-21. doi: 10.1016/j.ophtha.2007.06.013. Epub 2007 Aug 15.

  PMID: 17698198 BACKGROUND

• McKean-Cowdin R, Wang Y, Wu J, Azen SP, Varma R; Los Angeles Latino Eye Study Group. Impact of visual field loss on health-related quality of life in glaucoma: the Los Angeles Latino Eye Study. Ophthalmology. 2008 Jun;115(6):941-948.e1. doi: 10.1016/j.ophtha.2007.08.037. Epub 2007 Nov 12.

  PMID: 17997485 BACKGROUND

• Burr JM, Mowatt G, Hernandez R, Siddiqui MA, Cook J, Lourenco T, Ramsay C, Vale L, Fraser C, Azuara-Blanco A, Deeks J, Cairns J, Wormald R, McPherson S, Rabindranath K, Grant A. The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health Technol Assess. 2007 Oct;11(41):iii-iv, ix-x, 1-190. doi: 10.3310/hta11410.

  PMID: 17927922 BACKGROUND

• Tang J, Liang Y, O'Neill C, Kee F, Jiang J, Congdon N. Cost-effectiveness and cost-utility of population-based glaucoma screening in China: a decision-analytic Markov model. Lancet Glob Health. 2019 Jul;7(7):e968-e978. doi: 10.1016/S2214-109X(19)30201-3. Epub 2019 May 20.

  PMID: 31122906 BACKGROUND

• John D, Parikh R. Cost-effectiveness of community screening for glaucoma in rural India: a decision analytical model. Public Health. 2018 Feb;155:142-151. doi: 10.1016/j.puhe.2017.11.004. Epub 2018 Feb 2.

  PMID: 29407529 BACKGROUND

• Hulley, S. B. (2007). Designing clinical research (3rd ed.) Philadeiphia, PA: Lippioncott Williams and Wilkins.

  BACKGROUND

MeSH Terms

Conditions

Hypersensitivity; Glaucoma

Condition Hierarchy (Ancestors)

Immune System Diseases; Ocular Hypertension; Eye Diseases

Study Officials

• Nathan Congdon, MD MPH

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 9, 2021
• Study Start: November 22, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 years after the conclusion of the study
• Access Criteria: Reasonable request

Locations

VN (1)