Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

This study has been completed.

Sponsor:

Collaborator:

University of Southern California

Information provided by (Responsible Party):

Rebiscan, Inc.

ClinicalTrials.gov Identifier:

NCT01706991

First received: October 5, 2012

Last updated: October 12, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2012

Last Updated Date

October 12, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Binocularity score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01706991 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Presence of amblyopia risk factors [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Official Title ^ICMJE

MEPEDS New Device Pediatric Vision Scanner

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Children presenting for ophthalmic exam at eye clinic.

Condition ^ICMJE

Amblyopia
Strabismus

Intervention ^ICMJE

Device: Pediatric Vision Scanner eye scan

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

Study Group/Cohort (s)

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

Intervention: Device: Pediatric Vision Scanner eye scan
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.
Intervention: Device: Pediatric Vision Scanner eye scan
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.

Intervention: Device: Pediatric Vision Scanner eye scan

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. Print 2011 Jul.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

6 Months to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01706991

Other Study ID Numbers ^ICMJE

rebiscan-003

Has Data Monitoring Committee

Not Provided

Responsible Party

Rebiscan, Inc.

Study Sponsor ^ICMJE

Rebiscan, Inc.

Collaborators ^ICMJE

University of Southern California

Investigators ^ICMJE

Principal Investigator:

Rohit Varma, MD, PhD

University of Southern California

Information Provided By

Rebiscan, Inc.

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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