CataractNCT05213390

Autonomous Telephone Follow-up After Cataract Surgery

A study testing Dora in people with Cataract and After Cataract, run by University of Plymouth at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Cataract, After Cataract
What is being tested?: Dora
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 2 sitesUnited Kingdom
Study dates: 17 Sep 2021to 24 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Imperial College Healthcare NHS Trust
London
Oxford University Hospitals NHS Foundation Trust
Oxford

Other trials in United Kingdom

About this study

Official title: A Clinical Investigation of an Autonomous Phone Conversational Agent for Cataract Surgery Follow-up

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.

Read the detailed description

Background

Due to an ageing population and increased expectation, the demand for many services is exceeding the capacity of the clinical workforce. As a result, staff are facing a crisis of burnout from being pressured to deliver high- volume workloads, driving increasing costs for providers. Artificial intelligence, in the form of conversational agents, presents a possible opportunity to enable efficiencies in the delivery of care.

Aims and Objectives

This study aims to evaluate the effectiveness, usability and acceptability of DORA - an AI-enabled autonomous telemedicine call - for detection of post-operative cataract surgery patients who require further assessment. The study's objectives are: to establish efficacy of DORA's decision making in comparison to an expert human clinician; baseline sensitivity and specificity for detection of true complications; evaluation of patient acceptability; evidence for cost-effectiveness; and to capture data that may support further studies.

Project plan and methods used

Based on implementation science, the interdisciplinary study will be a mixed-methods phase one pilot establishing inter-observer reliability; as well as usability and acceptability.

Timelines for delivery

The study will last eighteen months: seven months of evaluation and intervention refinement, nine months of implementation and follow-up, and two months of post-evaluation analysis and write-up.

Anticipated Impact and Dissemination

The project's key contributions will be evidence on artificial intelligence voice conversational agent effectiveness, and associated usability and acceptability. Results will be disseminated in peer-reviewed journals and at international medical sciences and engineering conferences.

Conditions: Cataract, After Cataract
Being tested: Dora
Medical subject headings: Cataract, Capsule Opacification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoraOther
DORA uses a variety of AI technologies to deliver the patient follow-up call, including: speech transcription, natural language understanding, a machine-learning conversation model to enable contextual conversations, and speech generation. Together, these technologies cover the input, processing and analysis, and output needed to maintain a natural conversation. DORA is configured to deliver calls through a telephone connection as a real-time, stand-alone system: the operator inputs individual patient details to initiate the call and completes a summary in the electronic health record (EHR) afterwards.

Study groups in NCT05213390
Study group	Role	What they receive
Dora follow-up phone call	Experimental	DORA uses a variety of AI technologies to deliver the patient follow-up call, including: speech transcription, natural language understanding, a machine-learning conversation model to enable contextual conversations, and speech generation. Together, these technologies cover the input, processing and analysis, and output needed to maintain a natural conversation. DORA is configured to deliver calls through a telephone connection as a real-time, stand-alone system: the operator inputs individual patient details to initiate the call and completes a summary in the electronic health record (EHR) afterwards. The entire conversation will be supervised by a clinician. This clinician will be able to interrupt the call at any point if the system fails, the patient struggles to interact with it, or DORA does not collect sufficient information from the patient. The clinician will record a clinical assessment which will be compared to the DORA assessment. Receives: Other: Dora

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Clinical Complications Identified or Missed by DORA System
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
Measured: Up to 90 days post surgery
Calls Completed Without Intervention
Number of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions
Measured: Dora calls lasted an average of 7.5 minutes
System Usability
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Measured: Usability assessments were completed up to 6 months after the Dora call
Usability of Telehealth System Implementation
Measured using the Telehealth Usability Questionnaire (minimum score of 1, maximum score of 5, averaged across 19 items; higher scores indicate better usability)
Measured: Usability was assessed up to 6 months after the call
Qualitative Patient Perspectives of Usability
Qualitative feedback from semi-structured interviews
Measured: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Acceptability of AI Follow-up Phone Call
Qualitative feedback from semi-structured interviews
Measured: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Satisfaction With AI Follow-up Phone Call
Qualitative feedback from semi-structured interviews
Measured: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Appropriateness of AI for Follow-up Assessment
Qualitative feedback from semi-structured interviews
Measured: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Cost Impact
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).
Measured: Conducted 6 months after baseline
Subsequent Unplanned Follow-up
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.
Measured: Up to 90 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202124 Mar 2022

First posted28 Jan 2022
Study start17 Sep 2021
Primary completion31 Jan 2022
Study completion24 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: The study will be a multi-centre, mixed-methods clinical investigation to develop evidence regarding the feasibility, acceptability and potential effectiveness of Dora.
Masking: None (open label)
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05213390
Sponsor's protocol ID: 21WE6780
Status last verified: Jan 2025
First submitted: 8 Nov 2021
Last updated: 13 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Milne-Ives M, de Cock C, Lim E, Shehadeh MH, de Pennington N, Mole G, Normando E, Meinert E. The Effectiveness of Artificial Intelligence Conversational Agents in Health Care: Systematic Review. J Med Internet Res. 2020 Oct 22;22(10):e20346. doi: 10.2196/20346.
PubMed 33090118
de Pennington N, Mole G, Lim E, Milne-Ives M, Normando E, Xue K, Meinert E. Safety and Acceptability of a Natural Language Artificial Intelligence Assistant to Deliver Clinical Follow-up to Cataract Surgery Patients: Proposal. JMIR Res Protoc. 2021 Jul 28;10(7):e27227. doi: 10.2196/27227.
PubMed 34319248
Milne-Ives M, Homer SR, Andrade J, Meinert E. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis. Mayo Clin Proc Innov Qual Outcomes. 2025 May 27;9(3):100625. doi: 10.1016/j.mayocpiqo.2025.100625. eCollection 2025 Jun.
PubMed 40503087
Meinert E, Milne-Ives M, Lim E, Higham A, Boege S, de Pennington N, Bajre M, Mole G, Normando E, Xue K. Accuracy and safety of an autonomous artificial intelligence clinical assistant conducting telemedicine follow-up assessment for cataract surgery. EClinicalMedicine. 2024 Jul 3;73:102692. doi: 10.1016/j.eclinm.2024.102692. eCollection 2024 Jul.
PubMed 39050586

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Investigation of an Autonomous Phone Conversational Agent for Cataract Surgery Follow-up
ClinicalTrials.gov ID: NCT05213390
Acronym / sponsor ID: 21WE6780
Conditions: Cataract, After Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: University of PlymouthUniversity, hospital or other
Collaborators: University of Oxford, Imperial College London
Study start: 17 Sep 2021 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 24 Mar 2022 (actual)
First posted: 28 Jan 2022 (actual)
Results: Posted 13 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background

Aims and Objectives

Project plan and methods used

Based on implementation science, the interdisciplinary study will be a mixed-methods phase one pilot establishing inter-observer reliability; as well as usability and acceptability.

Timelines for delivery

The study will last eighteen months: seven months of evaluation and intervention refinement, nine months of implementation and follow-up, and two months of post-evaluation analysis and write-up.

Anticipated Impact and Dissemination

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study will be a multi-centre, mixed-methods clinical investigation to develop evidence regarding the feasibility, acceptability and potential effectiveness of Dora.

Arm	Type	Receives
Dora follow-up phone call	Experimental	Other: DoraDORA uses a variety of AI technologies to deliver the patient follow-up call, including: speech transcription, natural language understanding, a machine-learning conversation model to enable contextual conversations, and speech generation. Together, these technologies cover the input, processing and analysis, and output needed to maintain a natural conversation. DORA is configured to deliver calls through a telephone connection as a real-time, stand-alone system: the operator inputs individual patient details to initiate the call and completes a summary in the electronic health record (EHR) afterwards. The entire conversation will be supervised by a clinician. This clinician will be able to interrupt the call at any point if the system fails, the patient struggles to interact with it, or DORA does not collect sufficient information from the patient. The clinician will record a clinical assessment which will be compared to the DORA assessment.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DoraDORA uses a variety of AI technologies to deliver the patient follow-up call, including: speech transcription, natural language understanding, a machine-learning conversation model to enable contextual conversations, and speech generation. Together, these technologies cover the input, processing and analysis, and output needed to maintain a natural conversation. DORA is configured to deliver calls through a telephone connection as a real-time, stand-alone system: the operator inputs individual patient details to initiate the call and completes a summary in the electronic health record (EHR) afterwards.	Other	Dora follow-up phone call

Primary outcome

Agreement
Time frame: 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

10 secondary outcomes

Clinical Complications Identified or Missed by DORA System
Time frame: Up to 90 days post surgery
Calls Completed Without Intervention
Time frame: Dora calls lasted an average of 7.5 minutes
System Usability
Time frame: Usability assessments were completed up to 6 months after the Dora call
Usability of Telehealth System Implementation
Time frame: Usability was assessed up to 6 months after the call
Qualitative Patient Perspectives of Usability
Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Acceptability of AI Follow-up Phone Call
Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Satisfaction With AI Follow-up Phone Call
Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Appropriateness of AI for Follow-up Assessment
Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Cost Impact
Time frame: Conducted 6 months after baseline
Subsequent Unplanned Follow-up
Time frame: Up to 90 days post surgery

Results and safety

Results posted to the registry on 13 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dora Follow-up Phone Call	225	202

Primary outcome: Agreement

Time frame: Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes. Count of participants. Unit: Participants

Measure	Dora Outcome Decision n = 195	Supervising Clinician Decision n = 195
Discharge	117	131
Review	78	64

Population analysed: Calls to 7 of the 202 were incomplete.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 months post cataract surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dora Follow-up Phone Call	0 of 202 (0%)	4 of 202 (2%)	0 of 202

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33090118Milne-Ives M, de Cock C, Lim E, Shehadeh MH, de Pennington N, Mole G, Normando E, Meinert E. The Effectiveness of Artificial Intelligence Conversational Agents in Health Care: Systematic Review. J Med Internet Res. 2020 Oct 22;22(10):e20346. doi: 10.2196/20346.
Background: PubMed 34319248de Pennington N, Mole G, Lim E, Milne-Ives M, Normando E, Xue K, Meinert E. Safety and Acceptability of a Natural Language Artificial Intelligence Assistant to Deliver Clinical Follow-up to Cataract Surgery Patients: Proposal. JMIR Res Protoc. 2021 Jul 28;10(7):e27227. doi: 10.2196/27227.
Derived from this study: PubMed 40503087Milne-Ives M, Homer SR, Andrade J, Meinert E. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis. Mayo Clin Proc Innov Qual Outcomes. 2025 May 27;9(3):100625. doi: 10.1016/j.mayocpiqo.2025.100625. eCollection 2025 Jun.
Derived from this study: PubMed 39050586Meinert E, Milne-Ives M, Lim E, Higham A, Boege S, de Pennington N, Bajre M, Mole G, Normando E, Xue K. Accuracy and safety of an autonomous artificial intelligence clinical assistant conducting telemedicine follow-up assessment for cataract surgery. EClinicalMedicine. 2024 Jul 3;73:102692. doi: 10.1016/j.eclinm.2024.102692. eCollection 2024 Jul.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eduardo Normando, MD, PhD study chair

Imperial College London

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dora in people with Cataract and After Cataract, run by University of Plymouth at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement (time frame: Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05213390, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.