N/A
N=91
Mobile Medical Application for Cost-effective Strabismus Screening
Strabismus
Bottom Line
View on ClinicalTrials.gov: NCT03450980 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Comparison of App-measured Eye Deviation Angles to Gold Standard — 3.3 prism diopter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of App-measured Eye Deviation Angles to Gold Standard |
3.3 | — |
Summary
Develop and evaluate a new smartphone based app to screen for and measure eye misalignment (strabismus). The investigators will validate the app against simulated strabismus of known magnitude and common clinical tests. They will evaluate the app as a screening tool in high risk populations, to determine the sensitivity and specificity. They hypothesize that the app can measure to within 2 units (prism diopters) of the ground truth, and that it will be correlated with gold standard tests.
Eligibility Criteria
Inclusion Criteria
Ground Truth Aim Study:
- Age 18 to 88 years
- Normal or corrected to normal vision
Clinical Aim Study:
- Ages 18 to 88
- Strabismus
- Able to keep looking at a visual target for 30-60 seconds
Exclusion Criteria
Ground Truth Aim Study:
- Age less than 18 years or greater than 88.
Clinical Study:
- Age less than 18 or greater than 88
- Inability to keep looking at a visual target for 30-60 seconds
Data sourced from ClinicalTrials.gov (NCT03450980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.