An observational study in Amblyopia and Strabismus, sponsored by Rebiscan, Inc.. Completed at 1 site in United States. Open to participants aged 6 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-15.
Sponsored by Rebiscan, Inc. · Observational
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. All tests and observations will be done at a single visit over the course of approximately 30 minutes.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 32 is below the median of 156 across 37 observational studies indexed under Amblyopia.
Browse Amblyopia studies →Rebiscan, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children presenting for ophthalmic exam at eye clinic.
Exclusion Criteria:
Structurally normal eye with equal visual acuity and normal stereopsis.
Device: Pediatric Vision Scanner eye scan
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 eye scan
(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 eye scan
Subject is scanned with a 2.5 second pediatric vision scanner device test.
Binocularity score
Time frame: Day 1
Presence of amblyopia risk factors
Time frame: Day 1
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rebiscan, Inc.