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

NCT02536963 | Completed Results DMC

• 1 other identifier: R44EY025926
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Strabismus

Outcome Measures

Primary Outcomes (1)

• Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device

  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.

  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.

Study Arms (1)

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; Other: Reference examination

Interventions

Pediatric Vision Scanning device 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.

PVS Screening and reference examination

Reference examination OTHER

Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.

Also known as: Gold-standard eye exam

PVS Screening and reference examination

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 2-5 who present themselves to the pediatric clinic for well-visits.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• Kaiser Foundation Research Institute: collaborator

Study Sites (1)

Southern California Permanente Group

La Palma, California, 90623, United States

Location

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Results Point of Contact

• Title: CEO
• Organization: Rebiscan

jgshaka@rebiscan.com

857-600-0982

Study Officials

• Ashish Mehta, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 1, 2020
• Results First Posted: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)