Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

Sponsor
Uptown Eye Specialists (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766722
Collaborator
(none)
250
1
9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DORA AI
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility of an Artificial Intelligence Phone Call for Post-operative Care Following Cataract Surgery in a Diverse Population
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Dora is clinically safe [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.

  2. Dora is usable [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

  3. Dora is clinically appropriate [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

  4. Dora's clinical cost-effectiveness [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)

Secondary Outcome Measures

  1. Multi-lingual capacity of AI technology [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Uptown Eye Specialists

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sohel Somani, Dr. Sohel Somani, clinical professor, Uptown Eye Specialists
ClinicalTrials.gov Identifier:
NCT05766722
Other Study ID Numbers:
  • UptownEye3
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sohel Somani, Dr. Sohel Somani, clinical professor, Uptown Eye Specialists
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2023