Utility evaluation of AI based Mobile Refractor for Early Diagnosis of Childhood Refractive Error and Amblyopia Risk: Comparison of Domestic Medical Device with Overseas Multiple Devices

Evaluation of the usability of mobile-based optometry for early diagnosis of refractive error and amblyopia risk

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004275

Enrollment

500

Registered

2019-09-04

Start date

2019-11-11

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Photoscreening test by Kizopter(PD-01), Spot PediaVision(VS100S-2),PlusoptixA12(Plusoptix 12C(A-type)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age between 2 and 8 years old 2) who needs a photorefraction test 3) who voluntarily agrees to this study

Exclusion criteria

Exclusion criteria: 1) if they had eccentric fixation, optical media opacity, or the refractive errors of the eyes did not exceed a maximum limits of devices. 2) systemic or ocular pathology such as strabismus, glaucoma, cataract, or ocular surface disease, and not having previous ocular surgery

Design outcomes

Primary

Measure	Time frame
The comparison to conformity degree of MR, CR and Photoscreeners(Kizopter, Sopt Pediavision, PlusoptixA12)	—

Secondary

Measure	Time frame
The comparison to sensitivity, sepcificity, drop out ration of Photoscreeners(Kizopter, Sopt Pediavision, PlusoptixA12)	—

Countries

Korea, Republic of

Contacts

Public ContactDong hui Lim

Samsung Medical Center

ku.hwang@samsung.com+82-2-3410-5478

Outcome results