CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 318 enrolled
Drug / intervention
Pediatric Vision Scanning device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02536963
NCT02536963N/ACompleted

Amblyopia and Strabismus Testing in Pediatrics

Rebiscan, Inc.·observational·Posted Sep 1, 2015·Updated Jul 1, 2020

In Brief

An observational study evaluating Pediatric Vision Scanning device and Reference examination for Amblyopia and Strabismus. Completed, enrolled 318 participants across 1 site.

Detailed Summary

Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children. The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 1, 2015
Enrollment StartJan 1, 2016
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.8 years ago

Interventions

Pediatric Vision Scanning devicedevice

The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.

Reference examinationother

Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.