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