Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Sponsor

Rebiscan, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01726842

Collaborator

Retina Foundation of the Southwest (Other)

300

Enrollment

Location

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia Strabismus	Device: Pediatric Vision Scanner

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Pediatric Vision Scanner for the Eradication of Amblyopia

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Normal Controls Structurally normal eye with equal visual acuity and normal stereopsis.	Device: Pediatric Vision Scanner Subject is scanned with a 2.5 second pediatric vision scanner device test.
Referral required Diagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: VA <20/40 and 2 logMAR lines difference in normal eye Mild amblyopia (>20/40) Moderate amblyopia (20/40 and <20/100) Severe amblyopia (≥20/100 or worse) Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism. Strabismus: Constant: >2 PD at near and or distance. Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes. 'hypermetropia' (≥3.5 D), 'myopia' (≥-4.0 D), 'astigmatism' (≥1.5 D). 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.	Device: Pediatric Vision Scanner Subject is scanned with a 2.5 second pediatric vision scanner device test.
Borderline (no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.	Device: Pediatric Vision Scanner Subject is scanned with a 2.5 second pediatric vision scanner device test.

Arm

Intervention/Treatment

Normal Controls

Structurally normal eye with equal visual acuity and normal stereopsis.

Device: Pediatric Vision Scanner

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Referral required

Diagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: VA <20/40 and 2 logMAR lines difference in normal eye Mild amblyopia (>20/40) Moderate amblyopia (20/40 and <20/100) Severe amblyopia (≥20/100 or worse) Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism. Strabismus: Constant: >2 PD at near and or distance. Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes. 'hypermetropia' (≥3.5 D), 'myopia' (≥-4.0 D), 'astigmatism' (≥1.5 D). 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.

Device: Pediatric Vision Scanner

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Borderline

(no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.

Device: Pediatric Vision Scanner

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Outcome Measures

Primary Outcome Measures

Binocularity score [Day 1]

Secondary Outcome Measures

Presence of amblyopia risk factors [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion:

2-6 years old
complete ophthalmic examination including cycloplegic refraction conducted on the same day or within 3 months
strabismic, anisometropic, or normal (normal eye examination and refractive error according to AAPOS guidelines)
parent provides informed consent

Exclusion:

other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA, JRA, neurofibromatosis)
developmental delay
strabismus surgery in the past 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Foundation of the Southwest	Dallas	Texas	United States	75231

Sponsors and Collaborators

Rebiscan, Inc.
Retina Foundation of the Southwest

Investigators

Principal Investigator: Eileen Birch, PhD, Retina Foundation of the Southwest

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Rebiscan, Inc.

ClinicalTrials.gov Identifier:

NCT01726842

Other Study ID Numbers:

rebiscan-001

First Posted:

Nov 15, 2012

Last Update Posted:

Oct 29, 2015

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Amblyopia

Strabismus

Study Results

No Results Posted as of Oct 29, 2015