Retino-choroidal disease Eye Diseases
Conditions
Interventions
Current intervention as of 22/11/2021:
The intervention pathway is the tele-ophthalmology model for referral of patients with suspicion of retinal disease from community optometry to HES using a digit
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/11/2021: 1. Adult ( aged =18 years) attending the involved community optometry practices who underwent an OCT scan 2. People who at the opinion of the community optometrist have any suspicion of a retinal condition (including dry AMD, wet AMD, diabetic retinopathy, macular oedema, macular holes, epiretinal membranes, central serous chorio-retinopathy, genetic eye disease) 3. Macular OCT scan performed at community optometry _____ Previous inclusion criteria: 1. People attending the involved community optometry practices who underwent an OCT 2. People who at the opinion of the community optometrist have any suspicion of a retinal condition (including dry AMD, wet AMD, diabetic retinopathy, macular oedema, macular holes, epiretinal membranes, central serous chorio-retinopathy, genetic eye disease) 3. Macular OCT scan performed using either Topcon 3D OCT-2000 or Heidelberg OCT1 device (performed with Heidelberg ‘dense’ acquisition settings)
Exclusion criteria
Exclusion criteria: 1. People with any non-retinal ocular co-morbidities in either eye other than cataract 2. People with media opacities, inability to position or fixate or any other reason that prevents acquisition of good quality OCT scans (at the discretion of the community optometrist)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/11/2021: Cluster RCT: Proportion of false-positive referrals (unnecessary HES visits) in the current referral pathway and the teleophthalmology referral pathway (against the Reference Standard) at the end of the recruitment period. The primary endpoint selected is patient-centric, as unnecessary visits to HES are associated with significant anxiety and inconvenience for patients as demonstrated by pre-application PPI work, while at the same time having significant implications for NHS services in terms of costs and relative efficiency. AI study: We will adhere to the STARD publication standard in reporting the outcomes of the observational diagnostic accuracy study. The primary endpoint is diagnostic accuracy of the referral decision made by the Moorfields-DeepMind AI (refer to HES, do not refer to HES) against the Reference Standard (Moorfields Reading Centre). _____ Previous primary outcome measure: Cluster RCT: Proportion of false-positive referrals (unnecessary HES visits) in the current referral pathway and the teleophthalmology referral pathway (against the Reference Standard) at the end of the recruitment period. The primary endpoint selected is patient-centric as unnecessary visits to HES are associated with significant anxiety and inconvenience for patients as demonstrated by pre-application PPI work, while at the same time having significant implications for NHS services in terms of costs and relative efficiency. AI study: Diagnostic accuracy (sensitivity and specificity) of the referral decision made by the Moorfields-DeepMind AI (dichotomous analysis: refer to HES, do not refer to HES) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/11/2021: All measured at the end of recruitment: Cluster RCT: 1. Proportion of wrong diagnosis and wrong referral urgency (as a percentage %) in standard and teleophthalmology pathways against the reference standard 2. Proportion of false-negative referrals (as a percentage %) patients that would have benefited from a HES review) as well as sensitivity and specificity in standard and teleophthalmology pathways against the reference standard 3. Time from referral to consultation (in days) for urgent and routine referrals in standard and teleophthalmology pathways 4. Time from referral to treatment (in days) for urgent maculopathies (wet AMD and Retinal Vein Occlusions) in standard and teleophthalmology pathways 5. Number of uncommon referrals (rare disease) that can be safely triaged in the teleophthalmology pathway AI study: 1. Diagnostic accuracy (sensitivity and specificity) of Moorfields-DeepMind AI for the diagnosis of retinal disease 2. Diagnostic accuracy (sensitivity and specificity) of Moorfields-DeepMind AI for referral urgency (routine or urgent referral) 3. Proportion of false-positive referrals (as a percentage %) in the standard and teleophthalmology pathways when human assessors are replaced by the AI DSS 4. Proportion of wrong diagnosis and wrong referral urgency (as a percentage %) in the standard and teleophthalmology pathways when human assessors are replaced by AI DSS 5. Uptime and end-to-end inference speed (in seconds) of technical infrastructure supporting the AI DSS 6. Average time of end-to-end output (referral recommendation) by the AI DSS (in hours) 7. Modelled cost-consequences and net benefits of AI-enabled digital referral pathway using the same model as for the RCT to compare alternative diagnostic and referral strategies Pragmatic sub-study: 1. Proportion of false positive referrals (unnecessary HES visits) in the tele-ophthalmology referral pathway against the Reference Standard and the | — |
Countries
England, United Kingdom
Outcome results
None listed