Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

NCT05766722 | Unknown DMC

• 1 other identifier: UptownEye3
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (4)

• Dora is clinically safe

  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

  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

  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

  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 Outcomes (1)

• Multi-lingual capacity of AI technology

  through study completion, an average of 4 weeks

Study Arms (1)

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

EXPERIMENTAL

Device: DORA AI

Interventions

DORA AI DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uptown Eye Specialists: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Hannah Chiu, MD

CONTACT

4162920330; Hannah.H.Chiu@uptowneye.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sohel Somani, clinical professor

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: March 13, 2023
• Study Start: April 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03