Software Refraction With Mobilerone Versus Retinoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-46
SponsorBeijing Airdoc Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Software refraction with Eye Test Technology in a mobilerone
DeviceRefraction is done by software App by a mobilerone software installed.
Retinoscopy
DeviceRetinoscopy is an objective refraction method with retinoscope.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Software RefractionExperimental treatment 1 intervention
Group B: Refraction by retinoscopyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Spherical Equivalence(D)
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Time frame
1-day and within 2 weeks2
Astigmatism Power(D)
Cylinder value of each total astigmatism power
Time frame
1-day and within 2 weeks3
Astigmatism axial
Cylinder axis of astigmatism
Time frame
1-day and within 2 weeks4
pupil distance (mm)
pupil distance measurement with software or autorefractor
Time frame
1-day and within 2 weeksSecondary outcomes
1
Efficacy of test time (minutes)
How long for each test
Time frame
1-day and within 2 eeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Airdoc Technology Co., Ltd.
Lead sponsor
University of Notre Dame Australia
Collaborator
Source ClinicalTrials.gov