Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

March 22, 2023 updated by: Sohel Somani, Uptown Eye Specialists

Feasibility of an Artificial Intelligence Phone Call for Post-operative Care Following Cataract Surgery in a Diverse Population

To analyze the evidence for clinical safety, usability, acceptability, satisfaction, appropriateness, and cost-effectiveness of Dora for recognizing patients who require additional in-person evaluation post cataract surgery. To assess Dora's sensitivity and specificity in cataract surgery management To determine what can be learnt to enhance AI technology in the field of ophthalmology especially when working with culturally diverse patients such as Punjabi and Chinese speaking patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Cataract is defined as the degradation of the optical quality of the crystalline lens that affects vision and is the current leading cause of blindness worldwide. AI is set to revolutionize post-cataract surgery management by enhancing automation, increasing effectiveness, decreasing burdens placed on patients and the health care system. Ultimately, using AI-enabled automation could enhance patient management during and post cataract surgery.Cataract post-operative contact will be delivered by Dora agent, a natural language AI assistant.

Aim and objective:

Dora is a clinically safe, usable, appropriate, satisfactory and cost-effective AI technology for recognizing patients who require additional evaluation post cataract surgery.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are undergoing uncomplicated cataract surgery at a high volume surgical centre.

Exclusion Criteria:

  • clinically significant complications during surgery that require more than the standard postop treatment or follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients 18 years old or older undergoing uncomplicated cataract surgery.
Device: DORA AI
Dora will phone patients on the day of cataract surgery (2 to 4 hours after discharge home) and again at postoperative week three. Dora calls made on the day of surgery will evaluate if the patient has any acute post-operative concerns like pain, and will prompt a postoperative day 1 visit if necessary. Calls to Dora at postoperative week three will result in either a follow-up to check refractive difficulties and/or confirmation of second eye surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dora is clinically safe
Time Frame: through study completion, an average of 4 weeks
Clinical safety will be assessed using the comparison between Dora's clinical decision and the OT team's clinical decision.
through study completion, an average of 4 weeks
Dora is usable
Time Frame: through study completion, an average of 4 weeks
System usability scale will be used to assess usability of the technology. The scores are 0-100, a score above a 68 would be considered above average and anything below 68 is below average
through study completion, an average of 4 weeks
Dora is clinically appropriate
Time Frame: through study completion, an average of 4 weeks
System usability scale will be used to assess appropriateness of the technology. The scores are 0-100, a score above a 68 would be considered above average and anything below 68 is below average
through study completion, an average of 4 weeks
Dora's clinical cost-effectiveness
Time Frame: through study completion, an average of 4 weeks
Cost effectiveness will be assessed by comparing the cost of the system to the clinic specific costs (resources used and potential staff-hours) and patient specific costs (travel and time needed to be taken off from work)
through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multi-lingual capacity of AI technology
Time Frame: through study completion, an average of 4 weeks
To determine what can be learnt to enhance AI technology in the field of ophthalmology especially when working with culturally diverse patients such as Punjabi and Chinese speaking patients by holding interviews from a randomly selected pool of applicants selected for an in-depth interview to better understand their experience with Dora such as challenges regarding communication and comprehension of the technology.
through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptown Eye Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UptownEye3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on DORA AI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe