Trial Outcomes & Findings for Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening (NCT NCT02536963)

Last Updated: 2020-07-01

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

318 participants

Primary outcome timeframe

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.

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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. Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Overall Study STARTED	318
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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. Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Overall Study Withdrawal by Subject	18

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PVS Screening and Reference Examination n=300 Participants 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. 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. Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Age, Categorical <=18 years	300 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	4.0 years STANDARD_DEVIATION 1.16 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	63 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	70 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants
Region of Enrollment United States	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PVS Screening and Reference Examination n=300 Participants All enrolled participants were 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. 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 received a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results. Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device True positive - amblyopia with REFER result	6 Participants
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device True negative - control with PASS result	249 Participants
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device False negative - amblyopia with PASS result	0 Participants
Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device False positive - control with REFER result	45 Participants

Adverse Events

PVS Screening and Reference Examination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CEO

Rebiscan

Phone: 857-600-0982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place