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Completed

NCT Number: NCT07028359

Sharp Health Companion App for Cataract Surgery Preparation and Recovery

This randomized controlled trial evaluated the effectiveness of the Sharp Health Companion App, a smartphone-based digital health tool, compared to standard printed instructions for supporting older adults undergoing cataract surgery. The study enrolled 200 patients aged 39-86 from a high-volume ophthalmology practice. Participants were randomly assigned to either a printed instructions group or a group using the mobile app built on Apple's CareKit platform. Outcomes included surgery cancellation rates, day-of-surgery delays, medication adherence (both subjective and objective), visual acuity, and patient satisfaction. The app significantly reduced same-day surgery delays and improved objective medication adherence. The study was completed between December 2022 and January 2024 and was approved by the Sharp HealthCare Institutional Review Board (IRB #2209803).

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Key information

Conditions

Cataract Behavior Eye Diseases Health Behavior Lens Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Rees-Stealy Medical Group

San Diego, California, 92123, United States

About this study

This randomized controlled trial evaluated the effectiveness of the Sharp Health Companion App, a smartphone-based digital health tool, compared to standard printed instructions for supporting older adults undergoing cataract surgery. The study enrolled 200 patients aged 39-86 from a high-volume ophthalmology practice. Participants were randomly assigned to either a printed instructions group or a group using the mobile app built on Apple's open source CareKit platform. Outcomes included surgery cancellation rates, day-of-surgery delays, medication adherence (both subjective and objective), visual acuity, and patient satisfaction. The app significantly reduced same-day surgery delays and improved objective medication adherence. The study was completed between December 2022 and January 2024 and was approved by the Sharp HealthCare Institutional Review Board (IRB #2209803).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Scheduled for first-time cataract surgery at Sharp HealthCare Best-corrected visual acuity of 20/40 or worse Able to provide informed consent English-speaking For Group 2: possession of an iPhone and ability to use smartphone functions (e.g., Face ID or passcode)

Exclusion criteria

History of prior cataract surgery Significant cognitive, visual, or physical impairment preventing use of the app Inability to follow study procedures or complete follow-up Lack of access to compatible technology (Group 2 only)

Treatment and study plan

Printed Instructions with Phone Reminders

Behavioral

Participants received paper-based instructions for perioperative care, including medication, fasting, and follow-up logistics. Automated phone calls were sent before surgery to reinforce preparation. Participants used a printed checklist to self-report eye drop adherence.

Sharp Health Companion App (CareKit)

Behavioral

The Sharp Health Companion App delivered interactive digital perioperative checklists, medication adherence prompts, COVID-19 protocol reminders, symptom tracking, and educational videos via iPhone. Participants logged their medication use in real time on the Sharp Health Companion App. Printed instructions were provided as a backup.

Primary outcomes

  1. Objective Medication Adherence Rate

    Time frame: 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  2. Same-Day Cataract Surgery Delay Rate

    Time frame: Day of Surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  3. Cataract Surgery Cancellation Rate

    Time frame: Day of schedule surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

Secondary outcomes

  1. Self-Reported Medication Adherence

    Time frame: 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  2. Visual Acuity Outcome

    Time frame: Baseline to 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  3. Patient Reported Surgical Experience Score

    Time frame: 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  4. Postoperative custodial macular edema (CME) incidence

    Time frame: 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

  5. Postoperative Iritis Incidence

    Time frame: 30 days post-surgery

    Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Official study title

Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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