Performance of plusoptiX A09 Pediatric Autorefractor and Jaeb Visual Acuity Screener in Pediatric Vision Screening
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 10-006134
Sponsor Protocol Number: 10-006134
About this study
The purpose of this study is to provide pilot data on the sensitivity and specificity of two screening instruments, the plusoptiX A09 and the Jaeb Visual Acuity Screener in detecting amblyopia, strabismus and refractive error in young children, using a full eye examination as the gold standard.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Children aged 2 to 7 years (inclusive)
- Scheduled to receive full eye examination
- Able to read or match letter optotypes
- Measurable visual acuity
Exclusion Criteria:
- Existing eye condition causing severely reduced visual acuity that cannot be quantified using testing methods
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Tomohiko Yamada, O.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available