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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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
- 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.
- 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.
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
|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|
|United States, California|
|Southern California Permanente Group||Recruiting|
|La Palma, California, United States, 90623|
|Contact: Ashish Mehta, MD|
|Principal Investigator:||Ashish Mehta, MD||Kaiser Permanente|