Software Refraction With Mobilerone Versus Retinoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy

Conditions
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Myopia, Myopia, Moderate, Astigmatism

Intervention / Treatment
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* Device: Software refraction with Eye Test Technology in a mobilerone
* Device: Retinoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Software Refraction<br>Refraction is done by software with subjective refraction through a mobilerone. | Device: Software refraction with Eye Test Technology in a mobilerone<br>* Refraction is done by software App by a mobilerone software installed.<br>* Other names: Online refraction or App refraction with Eye Test Technology;|
| Active Comparator: Refraction by retinoscopy<br>Refraction is done objectively by retinoscopy. | Device: Retinoscopy<br>* Retinoscopy is an objective refraction method with retinoscope.<br>* Other names: Refraction by retinoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalence(D) | Spherical is myopic equivalence with total spherical plus half the cylinder diopter. | 1-day and within 2 weeks | 
| Astigmatism Power(D) | Cylinder value of each total astigmatism power | 1-day and within 2 weeks | 
| Astigmatism axial | Cylinder axis of astigmatism | 1-day and within 2 weeks | 
| pupil distance (mm) | pupil distance measurement with software or autorefractor | 1-day and within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of test time (minutes) | How long for each test | 1-day and within 2 eeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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software, refraction, subjective refraction, mobilerone, myopia, astigmatism