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

NCT ID: NCT02536963

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 318 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

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.

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).

Conditions

Amblyopia; Strabismus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pediatric Vision Scanning device

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Reference examination

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

Intervention Type: OTHER

Other Intervention Names

Gold-standard eye exam

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Foundation Research Institute

OTHER

Sponsor Role: collaborator

Rebiscan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashish Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Southern California Permanente Group

La Palma, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

R44EY025926

Identifier Type: NIH

Identifier Source: org_study_id

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