Mobile Medical Application for Cost-effective Strabismus Screening

Overseen By Sheryl Erwin, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Age, Inability to focus

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

190 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is developing a smartphone app to detect eye misalignment in children. The app uses the phone's camera to take pictures and measure alignment by analyzing light reflections on the eyes. Early detection can help prevent long-term vision problems.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the EyeTurn App treatment?

Research on similar mobile applications shows that they can improve patient engagement and satisfaction by providing education and real-time feedback, which may enhance the overall treatment experience and outcomes. ^{1 2 3 4 5}

Research Team

Kevin E Houston, OD

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

Inclusion Criteria

Ages 18 to 88

Age 18 to 88

Strabismus

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Develop and test key functionality of the strabismus app by comparing measurements with successive versions of the prototype app to known angles of eye deviation

15 minutes per session

Multiple sessions

Clinical Evaluation

Evaluate the strabismus app accuracy and feasibility in a clinical environment

1 year

Ongoing monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EyeTurn App

Participant Groups

Group I: EyeTurn App Experimental Treatment 1 Intervention

All participants will have their eye alignment measured with both the experimental device (EyeTurn app) and the clinical gold standard tests or ground truth (simulated strabismus gaze angles).

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

The open access mobile app for patient education on orthopedic injuries was downloaded 725 times and viewed over 9,000 times in 34 months, indicating strong interest and engagement among users.

Most users (55%) found the app helpful, and 78% would recommend it, although older patients (over 55 years) showed significantly lower participation rates, highlighting a potential gap in accessibility for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Trauma Patient Experience Through Education and Engagement: Development of a Mobile Application. Childs, BR., Breslin, MA., Andres, BA., et al.[2022]

The SeamlessMD App significantly improved patient engagement and satisfaction during the perioperative period for 50 patients undergoing robotic lung cancer surgery, with over 74% finding it very or extremely useful.

Patients using the App reported a significant decrease in maximum pain levels and anxiety scores post-surgery, and 40.9% indicated that the health-checks helped them avoid unnecessary calls or hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. Kneuertz, PJ., Jagadesh, N., Perkins, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using a Mobile Application for Real-Time Collection of Patient-Reported Outcomes in Hepatopancreatobiliary Surgery within an ERAS® Pathway. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancing Trauma Patient Experience Through Education and Engagement: Development of a Mobile Application. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. [2019]

4. China pubmed.ncbi.nlm.nih.gov

Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a data-driven integrated management app for perioperative adverse events: protocol for a mixed-design study. [2023]