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Software Refraction With Mobilerone Versus Retinoscopy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06059521
Acronym
SRMR
Enrollment
120
Registered
2023-09-28
Start date
2023-07-15
Completion date
2030-12-30
Last updated
2023-09-28

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

Conditions

Astigmatism, Myopia, Myopia, Moderate

Keywords

software, refraction, subjective refraction, mobilerone, myopia, astigmatism

Brief summary

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

DEVICESoftware refraction with Eye Test Technology in a mobilerone

Refraction is done by software App by a mobilerone software installed.

DEVICERetinoscopy

Retinoscopy is an objective refraction method with retinoscope.

Sponsors

University of Notre Dame Australia
CollaboratorOTHER
Beijing Airdoc Technology Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 46 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Spherical Equivalence(D)1-day and within 2 weeksSpherical is myopic equivalence with total spherical plus half the cylinder diopter.
Astigmatism Power(D)1-day and within 2 weeksCylinder value of each total astigmatism power
Astigmatism axial1-day and within 2 weeksCylinder axis of astigmatism
pupil distance (mm)1-day and within 2 weekspupil distance measurement with software or autorefractor

Secondary

MeasureTime frameDescription
Efficacy of test time (minutes)1-day and within 2 eeksHow long for each test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026