NCT04885868

Brief Summary

Patients will have an automated call supervised by a human clinician to check how they are after uncomplicated cataract surgery as part of their standard of care. The study aims to evaluate the acceptability of this system through a net promoter score and for a subsection of patients using a qualitative interview.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

May 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

April 29, 2021

Last Update Submit

May 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • A score out of 10 rating the autonomous system

    The patient will score the autonomous system out of 10 and a subsection of patients will have qualitative interviews.

    It is anticipated the study will occur over 3 months

Interventions

This study assess acceptability of autonomous conversation as part of cataract surgery follow up.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing uncomplicated cataract surgery who are suitable for telephone follow up

You may qualify if:

  • Routine, first or second eye cataract surgery with intraocular lens implantation without complications.
  • Above the age of 16.
  • Capacity to give consent
  • Access to a phone number.
  • Satisfactory command of English for a phone-based consultation.

You may not qualify if:

  • Combined glaucoma surgery
  • Retinal or glaucoma laser treatment
  • Corneal dystrophy or grafts
  • Combined vitreoretinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Capsule Opacification

Condition Hierarchy (Ancestors)

CataractLens DiseasesEye Diseases

Study Officials

  • Guy Mole, BSc MBBS MSc

    Ufonia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Mole, BSc MBBS MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 13, 2021

Study Start

May 24, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

The researcher undertaking the qualitative interviews will get access to the patient identifier for those who have consented to take part in the interview so that they can access their contact details from the hospital record.

Shared Documents
CSR
Time Frame
The study findings will be submitted to a peer review journal within 6 months of study completion.
Access Criteria
This will likely be an open source journal