CClinicalTrials.gg
Not yet recruitingNCT05766722Updated Mar 23, 2023

Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

An interventional study of DORA AI in Cataract, sponsored by Uptown Eye Specialists. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Uptown Eye Specialists · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • Artificial Intelligence
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 250 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Uptown Eye Specialists is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • clinically significant complications during surgery that require more than the standard postop treatment or follow-up
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

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

    Device: DORA AI

Interventions

  • DeviceDORA 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.

06

What researchers measure

Primary outcomes

  1. Dora is clinically safe

    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

  2. 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

    Time frame: through study completion, an average of 4 weeks

  3. 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

    Time frame: through study completion, an average of 4 weeks

  4. 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)

    Time frame: through study completion, an average of 4 weeks

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05766722
Lead sponsor
Uptown Eye Specialists
Responsible party
Sohel Somani (Dr. Sohel Somani, clinical professor, Uptown Eye Specialists) — Principal investigator
First posted
Mar 13, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Nov 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Mar 23, 2023

Study contacts

Hannah Chiu, MD
Contact
Hannah.H.Chiu@uptowneye.ca
4162920330

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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