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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536963
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : July 1, 2020
Last Update Posted : July 1, 2020
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
Amblyopia Strabismus Device: Pediatric Vision Scanning device Other: Reference examination

Detailed Description:

After demonstrating feasibility, we will recruit 300 clinical trial participants during previously scheduled visits at two Kaiser Permanente of Southern California (KPSC) pediatric clinics. We will also send letters and placed phone calls to parents of eligible children who lived in cities proximal to the two clinics. Children will be considered eligible if age is ≥ 2 years old, less than 6 years old; have never visited an ophthalmologist (as this could indicate a pre-existing eye condition and/or introduce biased eye exam results if the physician had seen the patient before), are an active Kaiser Permanente member, and do not have a cognitive and/or developmental disability (ICD-10 codes Z82.79 and F84.0).

Interested participants will either visit an on-site ophthalmology clinic immediately following their pediatric visit or make a future appointment at one of two KPSC ophthalmology clinics. All study activities will be completed during one appointment. Research staff describe the study to parents and obtain informed consent, collected parent-reported demographic data about each participant, screen each participant using the PVS, and documented PVS results, test acquisition time, and participant cooperation. Testing will be performed in a dimly lit room with the child seated on a chair or parents lap. Per manufacturer recommendations, a background calibration measurement is first obtained off of the face with closed eyes. Then the child is asked to open both eyes and fixate on the smiley face target within the device while the binocular retinal polarization scan is performed. PVS results will be interpreted as either "pass" or "refer" based on manufacturer recommendations. Acquisition time is defined as time from when the research staff picked up the PVS to when the result is generated, and cooperation is defined as "excellent" or "fair" based on staff discretion (e.g., a patient who listens to instructions and completes the exam on the first try would be "excellent," whereas a patient who moves his/her head around during testing would be "fair"). A pediatric ophthalmologist masked to the PVS result then performs a gold standard eye examination. Possible gold standard examination results were "normal", "normal with risk factors" (Table Amblyopia Risk Factors - see protocol), "suspected binocular vision deficit," "suspected amblyopia," "amblyopia, "strabismus" and "amblyopia and strabismus." (Diagnostic Categories Rubric - see protocol). Results were mutually exclusive. To compare the PVS results to the gold standard eye examination among the 300 children eligible for analysis, we will perform a validation characteristics analysis with a 95% confidence interval (CI).

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Study Type : Observational
Actual Enrollment : 318 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Amblyopia and Strabismus Testing in Pediatrics
Study Start Date : January 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Group/Cohort Intervention/treatment
PVS Screening and reference examination
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. They will then receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.
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.

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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children aged 2-5 who present themselves to the pediatric clinic for well-visits.
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


Locations
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United States, California
Southern California Permanente Group
La Palma, California, United States, 90623
Sponsors and Collaborators
Rebiscan, Inc.
Kaiser Foundation Research Institute
Investigators
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Principal Investigator: Ashish Mehta, MD Kaiser Permanente
  Study Documents (Full-Text)

Documents provided by Rebiscan, Inc.:
Informed Consent Form  [PDF] August 18, 2015
Statistical Analysis Plan  [PDF] August 18, 2015
Study Protocol  [PDF] August 18, 2015

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Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT02536963    
Other Study ID Numbers: R44EY025926 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2015    Key Record Dates
Results First Posted: July 1, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020
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:
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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