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Software Refraction With Mobilerone Versus Retinoscopy (SRMR)

B

Beijing Airdoc Technology

Status

Enrolling

Conditions

Myopia
Astigmatism
Myopia, Moderate

Treatments

Device: Retinoscopy
Device: Software refraction with Eye Test Technology in a mobilerone

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06059521
AirdocSoftwareEyeTest

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

10 to 46 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Software Refraction
Experimental group
Description:
Refraction is done by software with subjective refraction through a mobilerone.
Treatment:
Device: Software refraction with Eye Test Technology in a mobilerone
Refraction by retinoscopy
Active Comparator group
Description:
Refraction is done objectively by retinoscopy.
Treatment:
Device: Retinoscopy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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