NCT03450980

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

February 7, 2018

Results QC Date

April 15, 2023

Last Update Submit

June 21, 2025

Conditions

Strabismus

Keywords

Double Vision, Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Comparison of App-measured Eye Deviation Angles to Gold Standard

    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).

    15 minutes

Study Arms (1)

Strabismus

Participants with strabismus had measurement with the app and compared to the cover test with prism neutralization (gold standard) or eye turning to know eccentricity.

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal vision participants with simulated strabismus and participants with strabismus.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology of Clinical Research Office, Mass Eye and Ear

Boston, Massachusetts, 021141, United States

Location

Related Publications (14)

  • Brodie SE. Photographic calibration of the Hirschberg test. Invest Ophthalmol Vis Sci. 1987 Apr;28(4):736-42.

    PMID: 3557878BACKGROUND

  • Rowe, F.J., Clinical Orthoptics. 3rd ed. 2012: Wiley and Sons. 486.

    BACKGROUND

  • Taylor K, Elliott S. Interventions for strabismic amblyopia. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD006461. doi: 10.1002/14651858.CD006461.pub3.

    PMID: 21833955BACKGROUND

  • Cotter SA, Tarczy-Hornoch K, Song E, Lin J, Borchert M, Azen SP, Varma R; Multi-Ethnic Pediatric Eye Disease Study Group. Fixation preference and visual acuity testing in a population-based cohort of preschool children with amblyopia risk factors. Ophthalmology. 2009 Jan;116(1):145-53. doi: 10.1016/j.ophtha.2008.08.031. Epub 2008 Oct 29.

    PMID: 18962921BACKGROUND

  • Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.

    PMID: 21642624BACKGROUND

  • Barnard, S. and E. Johnson, Detecting strabismus. Optician, 2013.

    BACKGROUND

  • Klaver P, Marcar V, Martin E. Neurodevelopment of the visual system in typically developing children. Prog Brain Res. 2011;189:113-36. doi: 10.1016/B978-0-444-53884-0.00021-X.

    PMID: 21489386BACKGROUND

  • Williams C, Northstone K, Harrad RA, Sparrow JM, Harvey I; ALSPAC Study Team. Amblyopia treatment outcomes after screening before or at age 3 years: follow up from randomised trial. BMJ. 2002 Jun 29;324(7353):1549. doi: 10.1136/bmj.324.7353.1549.

    PMID: 12089090BACKGROUND

  • Epelbaum M, Milleret C, Buisseret P, Dufier JL. The sensitive period for strabismic amblyopia in humans. Ophthalmology. 1993 Mar;100(3):323-7. doi: 10.1016/s0161-6420(13)32170-8.

    PMID: 8460000BACKGROUND

  • Eibschitz-Tsimhoni M, Friedman T, Naor J, Eibschitz N, Friedman Z. Early screening for amblyogenic risk factors lowers the prevalence and severity of amblyopia. J AAPOS. 2000 Aug;4(4):194-9. doi: 10.1067/mpa.2000.105274.

    PMID: 10951293BACKGROUND

  • Lions C, Bui-Quoc E, Bucci MP. Postural control in strabismic children versus non strabismic age-matched children. Graefes Arch Clin Exp Ophthalmol. 2013 Sep;251(9):2219-25. doi: 10.1007/s00417-013-2372-x. Epub 2013 May 9.

    PMID: 23657730BACKGROUND

  • Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.

    PMID: 15824215RESULT

  • Hertle RW, Scheiman MM, Beck RW, Chandler DL, Bacal DA, Birch E, Chu RH, Holmes JM, Klimek DL, Lee KA, Repka MX, Weakley DR Jr; Pediatric Eye Disease Investigator Group. Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years. Arch Ophthalmol. 2007 May;125(5):655-9. doi: 10.1001/archopht.125.5.655.

    PMID: 17502505RESULT

  • Lukman H, Kiat JE, Ganesan A, Chua WL, Khor KL, Choong YF. Negative social reaction to strabismus in school children ages 8-12 years. J AAPOS. 2011 Jun;15(3):238-40. doi: 10.1016/j.jaapos.2011.01.158. Epub 2011 Jun 16.

    PMID: 21683635RESULT

MeSH Terms

Conditions

StrabismusDiplopiaAmblyopia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Results Point of Contact

Title
Gang Luo
Organization
Schepens Eye Research Institute of Mass Eye & Ear, Harvard Medical School, Boston, MA, USA
gang_luo@MEEI.HARVARD.EDU
(617) 573-4177

Study Officials

  • Gang Luo, PhD

    Massachusetts Eye and Ear

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 1, 2018

Study Start

February 1, 2018

Primary Completion

December 30, 2019

Study Completion

January 30, 2025

Last Updated

July 14, 2025

Results First Posted

July 14, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)