NCT05213390

Autonomous Telephone Follow-up After Cataract Surgery

Completed NA Results posted Last updated 13 January 2025

What this trial tests

NA trial testing Dora in Cataract in 225 participants. Completed in 24 March 2022.

Timeline

17 September 2021

Primary endpoint
31 January 2022

24 March 2022

Quick facts

Lead sponsor	University of Plymouth
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	225
Start date	17 September 2021
Primary completion	31 January 2022
Estimated completion	24 March 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Dora

Conditions studied

• Cataract — all drugs for Cataract →
• After Cataract — all drugs for After Cataract →

Sponsor

University of Plymouth

Who can join

Eligibility, any sex, with Cataract or After Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Agreement Primary · Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes

Inter-rater reliability: the degree of agreement between DORA and the clinician on their assessments of the individual symptoms and the management plan; Whether or not the clinician had to interrupt the call to ask clarifying questions

Group	Value	95% CI
Dora Outcome Decision	117
Supervising Clinician Decision	131
Dora Outcome Decision	78
Supervising Clinician Decision	64

Clinical Complications Identified or Missed by DORA System Secondary · Up to 90 days post surgery

Clinical data was collected from patients' electronic health record (EHR) up to 90 days postoperatively to capture numbers of participants 'recommended discharge' by Dora R1 with subsequent unexpected management change

Group	Value	95% CI
Unexpected Management Change	10

Calls Completed Without Intervention Secondary · Dora calls lasted an average of 7.5 minutes

Number of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions

Call completed autonomously

Group	Value	95% CI
Dora Follow-up Phone Call	195

Call incomplete

Group	Value	95% CI
Dora Follow-up Phone Call	7

System Usability Secondary · Usability assessments were completed up to 6 months after the Dora call

Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)

Group	Value	95% CI
Dora Follow-up Phone Call	77.76	± 17.55

Usability of Telehealth System Implementation Secondary · Usability was assessed up to 6 months after the call

Measured using the Telehealth Usability Questionnaire (minimum score of 1, maximum score of 5, averaged across 19 items; higher scores indicate better usability)

Group	Value	95% CI
Dora Follow-up Phone Call	3.79	± 0.89

Qualitative Patient Perspectives of Usability Secondary · Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

Qualitative feedback from semi-structured interviews

Burden

Group	Value	95% CI
Dora Follow-up Phone Call	18

Opportunity costs

Group	Value	95% CI
Dora Follow-up Phone Call	12

Self-efficacy

Group	Value	95% CI
Dora Follow-up Phone Call	5

Intervention coherence

Group	Value	95% CI
Dora Follow-up Phone Call	17

Acceptability of AI Follow-up Phone Call Secondary · Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

Qualitative feedback from semi-structured interviews

Affective attitude (anticipated)

Group	Value	95% CI
Dora Follow-up Phone Call	15

Affective attitude (experienced)

Group	Value	95% CI
Dora Follow-up Phone Call	20

Ethicality

Group	Value	95% CI
Dora Follow-up Phone Call	5

Satisfaction With AI Follow-up Phone Call Secondary · Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

Qualitative feedback from semi-structured interviews

Willing

Group	Value	95% CI
Dora Follow-up Phone Call	15

Not willing

Group	Value	95% CI
Dora Follow-up Phone Call	1

Hesitant, but willing

Group	Value	95% CI
Dora Follow-up Phone Call	4

Appropriateness of AI for Follow-up Assessment Secondary · Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

Qualitative feedback from semi-structured interviews

Perceived effectiveness (anticipated)

Group	Value	95% CI
Dora Follow-up Phone Call	4

Perceived effectiveness (experienced)

Group	Value	95% CI
Dora Follow-up Phone Call	19

Perceived effectiveness (long-term)

Group	Value	95% CI
Dora Follow-up Phone Call	19

Cost Impact Secondary · Conducted 6 months after baseline

A cost analysis compared the direct costs of face-to-face (F2F) follow-up at Imperial with Dora R1 (in Oxford, patients do not have routine postoperative follow-up). Assumptions included annual costs for various healthcare professionals and the duration of F2F follow-up appointments (estimated at 30 min).

Total staff cost (standard pathway)

Group	Value	95% CI
Dora Follow-up Phone Call	4555.16

Total staff cost (Dora pathway)

Group	Value	95% CI
Dora Follow-up Phone Call	1084.21

Subsequent Unplanned Follow-up Secondary · Up to 90 days post surgery

Clinical data was collected from patients' electronic health record (EHR) up to 90 days postoperatively to capture numbers of participants 'recommended discharge' by Dora R1 with subsequent unplanned review.

Group	Value	95% CI
Unplanned Follow-up	5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 months post cataract surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dora Follow-up Phone Call

Serious: 0/202 (0%)

Deaths: 0/202

Other adverse events (1 terms — click to expand)

Reaction	System	Dora Follow-up Phone Call
Symptomatic patients with unexpected management changes	Eye disorders	—

Data from ClinicalTrials.gov NCT05213390 adverse events section.

Sponsor's own description

This project will apply AI technology to meet the gap between increasing demand and limited capacity of high- volume healthcare services. The project will develop evidence that will support the safe deployment of Ufonia's automated telemedicine platform to deliver calls to cataract surgery patients at two large NHS hospital trusts.

The proposed study will implement DORA in addition to the current standard of care for a cohort of patients at Imperial College Healthcare Trust and Oxford University Hospitals NHS Foundation Trust. The study will evaluate the agreement of DORA's decision with an expert clinician. In addition it will test the acceptability of the solution for patients and clinicians; the sensitivity and specificity of the system in deciding if a patient requires additional review; and the health economic benefits of the solution to patients (reduced time and travel) and the local healthcare system. If successful, a proposal will be developed to roll the solution out to all patients at each site in anticipation of an application to a late phase award for wider NHS deployment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy and safety of an autonomous artificial intelligence clinical assistant conducting telemedicine follow-up assessment for cataract surgery.
   Meinert E, Milne-Ives M, Lim E, Higham A, et al · · 2024 · cited 12× · PMID 39050586 · DOI 10.1016/j.eclinm.2024.102692
2. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis.
   Milne-Ives M, Homer SR, Andrade J, Meinert E. · · 2025 · cited 1× · PMID 40503087 · DOI 10.1016/j.mayocpiqo.2025.100625