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Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DORA AI
Sponsored by
Uptown Eye Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cataract focused on measuring Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All patients 18 years old or older undergoing uncomplicated cataract surgery.

    Arm Description

    Outcomes

    Primary Outcome Measures

    Dora is clinically safe
    Clinical safety will be assessed using the comparison between Dora's clinical decision and the OT team's clinical decision.
    Dora is usable
    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
    Dora is clinically appropriate
    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
    Dora's clinical cost-effectiveness
    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

    Multi-lingual capacity of AI technology
    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.

    Full Information

    First Posted
    August 17, 2022
    Last Updated
    March 22, 2023
    Sponsor
    Uptown Eye Specialists
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05766722
    Brief Title
    Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery
    Official Title
    Feasibility of an Artificial Intelligence Phone Call for Post-operative Care Following Cataract Surgery in a Diverse Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uptown Eye Specialists

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Artificial Intelligence

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All patients 18 years old or older undergoing uncomplicated cataract surgery.
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    DORA AI
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Dora is clinically safe
    Description
    Clinical safety will be assessed using the comparison between Dora's clinical decision and the OT team's clinical decision.
    Time Frame
    through study completion, an average of 4 weeks
    Title
    Dora is usable
    Description
    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
    Time Frame
    through study completion, an average of 4 weeks
    Title
    Dora is clinically appropriate
    Description
    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
    Time Frame
    through study completion, an average of 4 weeks
    Title
    Dora's clinical cost-effectiveness
    Description
    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)
    Time Frame
    through study completion, an average of 4 weeks
    Secondary Outcome Measure Information:
    Title
    Multi-lingual capacity of AI technology
    Description
    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.
    Time Frame
    through study completion, an average of 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hannah Chiu, MD
    Phone
    4162920330
    Email
    Hannah.H.Chiu@uptowneye.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

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