CataractNCT07028359
Sharp Health Companion App for Cataract Surgery Preparation and Recovery
A study testing Printed Instructions with Phone Reminders and Sharp Health Companion App (CareKit) in people with Cataract, run by Sharp HealthCare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Printed Instructions with Phone Reminders and Sharp Health Companion App (CareKit)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
About this study
Official title: Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform
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).
Read the 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
- Being tested
- Printed Instructions with Phone Reminders, Sharp Health Companion App (CareKit)
- Keywords
- Cataract surgery, Mobile Health, Mhealth, Digital health, Medication adherence, Perioperative care, Older adults, Sharp health companion app, CareKit, iPhone
- Medical subject headings
- Cataract, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printed Instructions with Phone RemindersBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Printed Instructions + Phone Reminders | Active comparator | Participants 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. Receives: Behavioral: Printed Instructions with Phone Reminders |
| Group 2: Sharp Health Companion Mobile App Group | Experimental | Participants 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. Receives: Behavioral: Sharp Health Companion App (CareKit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Day of schedule surgery
Secondary outcomes (5)
Self-Reported Medication Adherence
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).
Measured: 30 days post-surgery
Visual Acuity Outcome
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).
Measured: Baseline to 30 days post-surgery
Patient Reported Surgical Experience Score
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).
Measured: 30 days post-surgery
Postoperative custodial macular edema (CME) incidence
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).
Measured: 30 days post-surgery
Postoperative Iritis Incidence
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).
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Dec 2022
- Primary completion28 Feb 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned 1:1 to printed instructions with phone reminders (Group 1) or to the Sharp Health Companion mobile app (Group 2), built using CareKit platform
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommy Korn, MD, Principal investigator, Sharp Rees-Stealy Medical Group and Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028359
- Sponsor's protocol ID
- SHARP-CAT-RCT2022
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korn TS, Assissini A, Slater LA, Holland J, Doone L, Lam E, Fox J, Greenwood KL, Linebarger E. Digital Health Support for Cataract Surgery With the Sharp Health Companion CareKit App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Apr 29;14:e78710. doi: 10.2196/78710.
PubMed 42055536
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform
- ClinicalTrials.gov ID
- NCT07028359
- Acronym / sponsor ID
- SHARP-CAT-RCT2022
- Conditions
- Cataract
- Keywords
- Cataract surgery, Mobile Health, Mhealth, Digital health, Medication adherence, Perioperative care, Older adults, Sharp health companion app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned 1:1 to printed instructions with phone reminders (Group 1) or to the Sharp Health Companion mobile app (Group 2), built using CareKit platform
| Arm | Type | Receives |
|---|---|---|
| Group 1: Printed Instructions + Phone Reminders | Active comparator | Behavioral: Printed Instructions with Phone RemindersParticipants 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 | Experimental | Behavioral: Sharp Health Companion App (CareKit)Participants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Printed Instructions with Phone RemindersParticipants 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. | Behavioural | Group 1: Printed Instructions + Phone Reminders |
| 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. | Behavioural | Group 2: Sharp Health Companion Mobile App Group |
Primary outcome
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).
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).
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).
5 secondary outcomes
Self-Reported Medication Adherence
Time frame: 30 days post-surgery
Visual Acuity Outcome
Time frame: Baseline to 30 days post-surgery
Patient Reported Surgical Experience Score
Time frame: 30 days post-surgery
Postoperative custodial macular edema (CME) incidence
Time frame: 30 days post-surgery
Postoperative Iritis Incidence
Time frame: 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 42055536Korn TS, Assissini A, Slater LA, Holland J, Doone L, Lam E, Fox J, Greenwood KL, Linebarger E. Digital Health Support for Cataract Surgery With the Sharp Health Companion CareKit App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Apr 29;14:e78710. doi: 10.2196/78710.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommy Korn, MD principal investigator
Sharp Rees-Stealy Medical Group and Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Printed Instructions with Phone Reminders and Sharp Health Companion App (CareKit) in people with Cataract, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Medication Adherence Rate (time frame: 30 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07028359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.