Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

Not Applicable

Not yet recruiting

• Conditions: Cataract
• Interventions: Device: DORA AI

• Registration Number: NCT05766722
• Lead Sponsor: Uptown Eye Specialists

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.

Study Timeline

• Study First Submitted: 2022-08-17
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-13
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Study Start: 2023-04-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients 18 years old or older undergoing uncomplicated cataract surgery.	DORA AI	-

Primary Outcome Measures

Name	Time	Method
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
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.
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
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

Name	Time	Method
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.