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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

October 5, 2012
October 12, 2012
January 2011
June 2011   (final data collection date for primary outcome measure)
Binocularity score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01706991 on ClinicalTrials.gov Archive Site
Presence of amblyopia risk factors [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
MEPEDS New Device Pediatric Vision Scanner

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children presenting for ophthalmic exam at eye clinic.

  • Amblyopia
  • Strabismus
Device: Pediatric Vision Scanner eye scan
Subject is scanned with a 2.5 second pediatric vision scanner device test.
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Both
6 Months to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01706991
rebiscan-003
Not Provided
Rebiscan, Inc.
Rebiscan, Inc.
University of Southern California
Principal Investigator: Rohit Varma, MD, PhD University of Southern California
Rebiscan, Inc.
October 2012

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