Software Refraction With Mobilerone Versus Retinoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Software refraction with Eye Test Technology in a mobilerone, Retinoscopy.
- Who it may be relevant to
- Registry conditions: Myopia, Myopia, Moderate, Astigmatism. Basic parameters: 10 years — 46 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
Overview
Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.
Detailed description
It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.
Interventions
- Device Software refraction with Eye Test Technology in a mobilerone
Refraction is done by software App by a mobilerone software installed. - Device Retinoscopy
Retinoscopy is an objective refraction method with retinoscope.
Primary outcome measures
- Spherical Equivalence(D) [Time frame: 1-day and within 2 weeks]
- Astigmatism Power(D) [Time frame: 1-day and within 2 weeks]
- Astigmatism axial [Time frame: 1-day and within 2 weeks]
- pupil distance (mm) [Time frame: 1-day and within 2 weeks]
Secondary outcome measures (1)
- Efficacy of test time (minutes) [Time frame: 1-day and within 2 eeks]
Eligibility criteria
Inclusion criteria
- • subject with ametropia on each eye ≤-12.00D
- subject with best corrected visual acuity ≥ 20/25, no amblyopia
- subject with normal transparency of eyes
- subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations
- subject able to cooperate with the screen and the operator
- subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
- non-diabetic subject
- non nystagmus subject
- non-strabismus subject
- subject who has not had eye surgery less than 1 year old
Exclusion criteria
- • subject with a topography showing an anomaly (keratoconus type or other)
- subject with hyperopia or presbyopia
- subject with mild myopia ≥ -1.00D
- subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 3 centers
- Airdoc MPC Opthalmology Clinics — Beijing
- Jenny QIU — Beijing
- Qiu Jenny — Beijing
Identifiers
NCT: NCT06059521 · AirdocSoftwareEyeTest