Trial Outcomes & Findings for Mobile Medical Application for Cost-effective Strabismus Screening (NCT NCT03450980)

Results Overview

Linear regression analysis was used to compare the app measurements of strabismus angle to ground truth and gold standard measures. The outcome measure is the difference between the two methods, in terms of least square mean (LSM).

Recruitment status

COMPLETED

Target enrollment

91 participants

Primary outcome timeframe

15 minutes

Results posted on

2025-07-14

Participant Flow

No significant event.

Participant milestones

Participant milestones
Measure	Participants With Varied Ocular Deviation This is an observation study, not an intervention study. This was only one group of participants, who were tested for ocular deviation by two methods.. All participants will have eye deviation due to strabismus or gaze shift.
Overall Study STARTED	91
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Varied Ocular Deviation n=91 Participants This is not an intervention study. There was one time observation using two different tests. Participants with ocular deviation due to either strabismus or gaze shift.
Age, Categorical <=18 years	36 Participants n=91 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=91 Participants
Age, Categorical >=65 years	0 Participants n=91 Participants
Sex/Gender, Customized Undisclosed	25 Participants n=91 Participants
Sex/Gender, Customized Male	36 Participants n=91 Participants
Sex/Gender, Customized Female	30 Participants n=91 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: Participants with Simulated Strabismus and Strabismus

Linear regression analysis was used to compare the app measurements of strabismus angle to ground truth and gold standard measures. The outcome measure is the difference between the two methods, in terms of least square mean (LSM).

Outcome measures

Outcome measures
Measure	Participants With Ocular Deviation n=91 Participants Participants with eye deviation due to strabismus or gaze shift.
Comparison of App-measured Eye Deviation Angles to Gold Standard	3.3 prism diopter Standard Deviation 4.2

Adverse Events

Participants With Ocular Deviation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gang Luo

Schepens Eye Research Institute of Mass Eye & Ear, Harvard Medical School, Boston, MA, USA

Phone: (617) 573-4177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place