N/A
Completed N=225
Autonomous Telephone Follow-up After Cataract Surgery
Cataract · After Cataract
Source: ClinicalTrials.gov NCT05213390 ↗
Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Agreement — 117; 131; 78; 64 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement |
117; 131; 78; 64 | — |
| SECONDARY Clinical Complications Identified or Missed by DORA System |
10 | — |
| SECONDARY Calls Completed Without Intervention |
195; 7 | — |
| SECONDARY System Usability |
77.76 | — |
| SECONDARY Usability of Telehealth System Implementation |
3.79 | — |
| SECONDARY Qualitative Patient Perspectives of Usability |
18; 12; 5; 17 | — |
| SECONDARY Acceptability of AI Follow-up Phone Call |
15; 20; 5 | — |
| SECONDARY Satisfaction With AI Follow-up Phone Call |
15; 1; 4 | — |
| SECONDARY Appropriateness of AI for Follow-up Assessment |
4; 19; 19 | — |
| SECONDARY Cost Impact |
4555.16; 1084.21 | — |
| SECONDARY Subsequent Unplanned Follow-up |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent;
- Aged 18 years or older;
- On the waiting list for routine cataract surgery. Cataract surgery as part of a combined procedure with other ocular surgery will not be included;
- No history or presence of significant ocular comorbidities that would be expected to alter the risks of cataract surgery or normal post-operative follow-up schedule. Note that significant ocular comorbidities do not include stable, chronic, or inactive ocular conditions such as amblyopia, drop-controlled stable glaucoma or ocular hypertension, previous squint surgery, inactive macular pathology, previous refractive surgery, or previous vitreoretinal surgery with stable retina.
Exclusion Criteria
- Individuals with any condition that could preclude the ability to comply with the study or follow-up procedures;
- Presence of ocular or systemic uncontrolled disease (unless deemed not clinically significant by the Investigator and Sponsor);
- Involved in current research related to this technology or been involved in related research to this technology prior to recruitment;
- Cognitive difficulties, hearing impairment or non-English speakers;
- History of current or severe, unstable or uncontrolled systemic disease (unless deemed not clinically significant by the Investigator and Sponsor).
Data sourced from ClinicalTrials.gov (NCT05213390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.