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Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening

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ClinicalTrials.gov Identifier: NCT02536963
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Rebiscan, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Amblyopia Strabismus Device: Pediatric Vision Scanning device Other: Reference examination Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: Amblyopia and Strabismus Testing in Pediatrics
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
PVS Screening
All enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit.
Device: Pediatric Vision Scanning device
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 examination
All enrolled participants will receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.
Other: Reference examination
Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Other Name: Gold-standard eye exam




Primary Outcome Measures :
  1. Detection of amblyopia and strabismus in children ages 8-10 using automated Pediatric Vision Scanner device [ Time Frame: Screenings will be performed during a normally scheduled well-child visit, which lasts on average 20 minutes. No follow on visits related to the screening or screening results will be required. ]
    Screening device will provide a binocularity score from 0-100. Scores ≥60 indicate "normal" exams, while scores <60 are "refers" for amblyopia and strabismus. Device results will be compared to visual acuity measure results by the pediatrician.

  2. Detection of amblyopia and strabismus in children ages 2-5 using automated Pediatric Vision Scanner device [ Time Frame: Screenings will be performed during a normally scheduled well-child visit, which lasts on average 20 minutes. Eye examinations for "refer" screenings will occur immediately after well-child visit. ]
    Screening device will provide a binocularity score from 0-100. Scores ≥60 indicate "normal" exams, while scores <60 are "refers" for amblyopia and strabismus. Device results will be compared to the gold standard eye examination performed by a pediatric ophthalmologist.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 8-10, presenting for a well-visit (for enrollment for first primary outcome)
  • Between the ages of 2-5, presenting for a well-visit (for enrollment for second primary outcome)

Exclusion Criteria:

  • No developmental delay or cognitive deficit
  • No visually obvious ocular conditions that would warrant specialist referral

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536963


Contacts
Contact: Ashish Mehta, MD 714-685-3641 Ashish.M.Mehta@kp.org
Contact: Donald Fong, MD, MPH 626-851-6105 Donald.S.Fong@kp.org

Locations
United States, California
Southern California Permanente Group Recruiting
La Palma, California, United States, 90623
Contact: Ashish Mehta, MD         
Sponsors and Collaborators
Rebiscan, Inc.
Kaiser Foundation Research Institute
Investigators
Principal Investigator: Ashish Mehta, MD Kaiser Permanente

Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT02536963     History of Changes
Other Study ID Numbers: R44EY025926 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared; cumulative results from the study may be presented in research journals and/or society conferences.

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases