EyeTurn App for Crossed Eyes

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called EyeTurn, designed to screen for and measure eye misalignment, known as strabismus. Researchers aim to determine if the app provides results comparable to traditional eye tests. The goal is to make strabismus screening easier and more accessible for those at high risk. Individuals with strabismus who can focus on a visual target briefly might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative technology that could simplify eye health monitoring for many.

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 prior data suggests that this app is safe for measuring eye misalignment?

Research shows that the EyeTurn app checks for eye misalignment by using a smartphone camera to analyze light reflections on the eyes. In earlier studies, the app accurately identified strabismus (eye misalignment) and matched the accuracy of other leading tests. Importantly, these studies reported no safety issues or side effects. The EyeTurn app functions like taking a photo, making it easy and comfortable for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EyeTurn App because it offers a cost-effective and accessible way to screen for strabismus, a condition where the eyes do not align properly. Unlike traditional methods that require specialized equipment and trained professionals, the EyeTurn App can be used on a mobile device, making it convenient for wider use, especially in underserved areas. Additionally, it aims to provide precise measurements of eye alignment comparable to clinical gold standard tests, potentially improving early detection and treatment outcomes.

What evidence suggests that the EyeTurn App is effective for screening eye misalignment?

Research has shown that the EyeTurn App, which participants in this trial will use, holds promise for checking eye misalignment, known as strabismus. In one study, the app accurately measured eye alignment in 93% of the children tested. Another comparison found that the app's results matched those of traditional tools, although they were slightly higher. Most users found the app helpful, with 78% willing to recommend it. These findings suggest the app could be an effective tool for screening strabismus. ^{1 4 6 7 8}

Who Is on the Research Team?

Gang Luo, PhD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

Inclusion Criteria

Ages 18 to 88

Age 18 to 88

Strabismus

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• EyeTurn App

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7992982/

A smartphone ocular alignment measurement app in ... The nurse obtained at least one successful app measurement for 93% of children (125/133). 40 were flagged for PACT, of which 6 were confirmed to have strabismus ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6369861/

Development and Preliminary Evaluation of a Smartphone ... Overall, the strabismus measurements with the app were higher than with Synoptophore (slope = 1.15, R2 = 0.91, P < 0.001), but consistent with ...

3. researchgate.net researchgate.net/publication/350385781_A_smartphone_ocular_alignment_measurement_app_in_school_screening_for_strabismus

(PDF) A smartphone ocular alignment measurement app in ... Results The nurse obtained at least one successful app measurement for 93% of children (125/133). 40 were flagged for PACT, of which 6 were ...

4. withpower.com withpower.com/trial/phase-strabismus-1-2018-719ac

Mobile Medical Application for Cost-effective Strabismus ... Most users (55%) found the app helpful, and 78% would recommend it, although older patients (over 55 years) showed significantly lower participation rates, ...

5. ctv.veeva.com ctv.veeva.com/study/mobile-medical-application-for-cost-effective-strabismus-screening

Mobile Medical Application for Cost-effective Strabismus ... The investigators will validate the app against simulated strabismus of known magnitude and common clinical tests. They will evaluate the app as ...

6. tvst.arvojournals.org tvst.arvojournals.org/article.aspx?articleid=2724671

Development and Preliminary Evaluation of a Smartphone ... The EyeTurn app has many unique features and differences compared to existing devices for strabismus detection and/or measurement, such as photoscreeners (Spot, ...

7. researchgate.net researchgate.net/publication/347698505_A_Smartphone_Ocular_Alignment_Measurement_App_in_School_Screening_for_Strabismus

(PDF) A Smartphone Ocular Alignment Measurement App ... Based on the ROC curve, the optimum threshold for the app to detect strabismus was determined to be 3.0△, with the best sensitivity (83.0%), specificity (76.5%) ...

8. eye.hms.harvard.edu eye.hms.harvard.edu/publications/smartphone-ocular-alignment-measurement-app-school-screening-strabismus

A smartphone ocular alignment measurement app in school ... The purpose of our study is to evaluate the feasibility of using a smartphone application in school vision screening for detection of strabismus. METHODS: The ...