Sharp Health Companion App for Cataract Surgery Preparation and Recovery
1 other identifier
interventional
200
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedJune 19, 2025
June 1, 2025
1.2 years
June 11, 2025
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Medication Adherence Rate
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).
30 days post-surgery
Same-Day Cataract Surgery Delay Rate
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).
Day of Surgery
Cataract Surgery Cancellation Rate
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).
Day of schedule surgery
Secondary Outcomes (5)
Self-Reported Medication Adherence
30 days post-surgery
Visual Acuity Outcome
Baseline to 30 days post-surgery
Patient Reported Surgical Experience Score
30 days post-surgery
Postoperative custodial macular edema (CME) incidence
30 days post-surgery
Postoperative Iritis Incidence
30 days post-surgery
Study Arms (2)
Group 1: Printed Instructions + Phone Reminders
ACTIVE COMPARATORParticipants in this arm received printed instructions for cataract surgery preparation and recovery, along with automated phone reminders. They used a printed checklist to track medication adherence. This group did not receive the Sharp Health Companion App.
Group 2: Sharp Health Companion Mobile App Group
EXPERIMENTALParticipants in this arm used the Sharp Health Companion App, a CareKit-based iPhone application, to receive digital pre- and postoperative instructions, medication reminders, and educational content. The app tracked medication adherence and surgical prep. Printed instructions were provided as backup.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sharp HealthCarelead
Study Sites (1)
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tommy Korn, MD
Sharp Rees-Stealy Medical Group and Sharp HealthCare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 19, 2025
Study Start
December 1, 2022
Primary Completion
February 28, 2024
Study Completion
September 30, 2024
Last Updated
June 19, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share