---
title: Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
nct_id: NCT01706991
overall_status: COMPLETED
sponsor: Rebiscan, Inc.
study_type: OBSERVATIONAL
primary_condition: Amblyopia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01706991.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01706991"
ct_last_update_post_date: 2012-10-15
last_seen_at: "2026-05-12T06:04:55.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

**Official Title:** MEPEDS New Device Pediatric Vision Scanner

**NCT ID:** [NCT01706991](https://clinicaltrials.gov/study/NCT01706991)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Rebiscan, Inc.
- **Collaborators:** University of Southern California
- **Conditions:** Amblyopia, Strabismus
- **Start Date:** 2011-01
- **Completion Date:** 2011-06
- **CT.gov Last Update:** 2012-10-15

## 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. All tests and observations will be done at a single visit over the course of approximately 30 minutes.

## Eligibility

- **Minimum age:** 6 Months
- **Maximum age:** 6 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Children aged 6 months to 6 years
* Signed Informed consent by parent or guardian
* Meet all inclusion criteria.

Exclusion Criteria:

* Children with a history of developmental delay or cognitive deficit
* Children unable to complete the GSE (including visual acuity testing)
```

## Arms

- **Normal Controls** — Structurally normal eye with equal visual acuity and normal stereopsis.
- **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.
- **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.

## Interventions

- **Pediatric Vision Scanner eye scan** (DEVICE) — Subject is scanned with a 2.5 second pediatric vision scanner device test.

## Primary Outcomes

- **Binocularity score** _(time frame: Day 1)_

## Secondary Outcomes

- **Presence of amblyopia risk factors** _(time frame: Day 1)_

## Locations (1)

- Doheny Eye Institute, Los Angeles, California, United States

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.doheny eye institute|los angeles|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01706991.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01706991*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*