Mobile Medical Application for Cost-effective Strabismus Screening

Strabismus Clinical Trial

Official title:

Mobile Medical Application for Cost-effective Strabismus Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03450980
• Other study ID #: 15-061H
• Secondary ID: 2R44EY025902-02
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2021
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Sheryl Erwin, BS
• Phone: 617-912-2505
• Email: sheryl_erwin[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of the proposed project is the development and evaluation of a novel mobile medical application for the detection and monitoring of strabismus (eye misalignment). The image analysis technology necessary to measure strabismus using the corneal reflection technique (Photographic Hirschberg Test) has been available for many decades, however it has never been deployed using a smart phone. A smart phone platform will eliminate barriers of cost (since the hardware is maintained and updated by the smart phone industry), leading to rapid wide spread application and allowing the technology to finally reach its potential level of impact for children's eye care in the detection and management of strabismus. Strabismus causes visual confusion and double vision which ultimately results in the brain suppressing vision from the deviated eye. In children this results in under-development (amblyopia) with permanent vision loss in the deviated eye if not detected and treated at a young age. Strabismus in children is also associated with coordination problems such as postural instability and severe social disadvantages. Strabismus develops in an estimated 3-8% of children in the U.S. The prototype smart phone app (Referred to here as the Mobile Eye Alignment App - MEAA), uses photographic analysis of the corneal reflection (Purkinjie image) generated by the smart phone camera flash. The corneal reflection method uses the displacement of the reflection from the center of the pupil in the deviated eye to calculate the amount of eye misalignment. This measurement technique will be deployed for the proposed project using the hardware of the iPhone, a popular phone with an iOS operating system. Preliminary results suggest the app can measure differences in eye alignment of 1.6° (2.8 prism diopters). If successfully developed, the app has potential to be utilized to advance pediatric strabismus research by facilitating and reducing the cost of collecting enormous amounts of data from the general population and under-served or remote populations for epidemiological studies, and allowing researchers to capture eye alignment data much more frequently than is currently possible. Such a tool could better delineate the natural history of strabismus and perhaps help determine its causes. While devices are available which could make these measurements, the costs are prohibitively high (>$3,000 ea.) and will not reach the widespread availability of smart phones. Clinical goals for the app are to provide eye doctors with an objective measurement tool in the exam room, allow daily monitoring of treatment effects, and eventually to be used as a screening tool by school nurses, pediatricians, and parents. The barriers to market success of stand-alone devices is not the accuracy sensitivity or specificity of photographic analysis technique which has been reported with sensitivity from 53% to near 90% and specificity ranging from 76% to 94% for strabismus detection. Impact of strabismus screening for the young - Early detection for strabismus in young children, especially during the critical period up to 2 years of age, is important to ensure that treatment is administered as soon as possible. The success of amblyopia treatment depends on several factors, but principally on the age of onset and the age at which the treatment is initiated. Therapy for amblyopia is maximally effective if started before age 3 and can be initiated as early as 8 months, underscoring the critical need for early and widespread access to strabismus screening. Indeed, countries with long-standing early vision screening programs have reported significantly reduced rates of amblyopia. Access to strabismus screening is also important for older, school age children (age 7-17) suffering from amblyopia, for whom treatment can lead to significant improvements in visual acuity ranging from 20%-70% of patients, depending on their age bracket.

Aims Specific Aim 1: 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 (non-strabismic volunteers will gaze at off axis targets of known eccentricity). Specific Aim 2: Evaluate the strabismus app accuracy and feasibility in a clinical environment.

Primary Hypothesis: For strabismus ranging from 1 to 30 prism diopters (target range), the optimized version of the app will provide measurements which are not significantly different from the ground truth (simulated strabismus) or clinical tests of eye alignment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

Ground Truth Aim Study (closed for recruitment):

• Age 18 to 88

• 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

• Able to report locations of visual targets during testing

Exclusion Criteria:

Ground Truth Aim Study:

• Age less than 18 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

• Inability to report locations of visual targets during testing

Related Conditions & MeSH terms

• Strabismus

Intervention

Other:
• EyeTurn App
App software which analyzes the position of ocular surface reflections in a photograph to quantify eye misalignment (strabismus)

Locations

Country	Name	City	State
United States	Ophthalmology of Clinical Research Office, Mass Eye and Ear	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (14)

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

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

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. Erratum in: Ophthalmology. 2009 Feb;116(2):174. — View Citation

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. — View Citation

Epelbaum M, Milleret C, Buisseret P, Dufier JL. The sensitive period for strabismic amblyopia in humans. Ophthalmology. 1993 Mar;100(3):323-7. — View Citation

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 treatme — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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 — View Citation

Taylor K, Elliott S. Interventions for strabismic amblyopia. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD006461. doi: 10.1002/14651858.CD006461.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;7:CD006461. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strabismus angle with the app compared to ground truth and gold standard tests	Strabismus angle is typically reported in prism diopters (PD) where 1PD = 0.57degrees.	15 minutes
Secondary	Perceived Value Survey	A 10 point likert-type rating scale to quantify the perceived value (1 low value to 10 high value) of the app tele-strabismus consultation (a subaim in the clinical evaluation aim)	5 minutes after completion of the tele-strabismus consult
Secondary	Test-Retest repeatability of the app	Strabismus angle	3 app measurements taken over approximately 1 minute
Secondary	Robustness	calculation of the percentage of capture failures (capture failures/ total number of attempted image captures)	1 year