NCT07028359

Sharp Health Companion App for Cataract Surgery Preparation and Recovery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Cataract

Interventions

Type	Name	Description
BEHAVIORAL	Printed Instructions with Phone Reminders	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.
BEHAVIORAL	Sharp Health Companion App (CareKit)	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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-02-28
• Completion: 2024-09-30
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States