SRMR: Software Refraction With Mobilerone Versus Retinoscopy

Sponsor

Beijing Airdoc Technology Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06059521

Collaborator

University of Notre Dame Australia (Other)

120

Enrollment

Locations

Arms

89.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Myopia, Moderate Astigmatism	Device: Software refraction with Eye Test Technology in a mobilerone Device: Retinoscopy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Software Refraction Refraction is done by software with subjective refraction through a mobilerone.	Device: Software refraction with Eye Test Technology in a mobilerone Refraction is done by software App by a mobilerone software installed. Other Names: Online refraction or App refraction with Eye Test Technology
Active Comparator: Refraction by retinoscopy Refraction is done objectively by retinoscopy.	Device: Retinoscopy Retinoscopy is an objective refraction method with retinoscope. Other Names: Refraction by retinoscopy

Arm

Intervention/Treatment

Experimental: Software Refraction

Refraction is done by software with subjective refraction through a mobilerone.

Device: Software refraction with Eye Test Technology in a mobilerone

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

Other Names:

Online refraction or App refraction with Eye Test Technology

Active Comparator: Refraction by retinoscopy

Refraction is done objectively by retinoscopy.

Device: Retinoscopy

Retinoscopy is an objective refraction method with retinoscope.

Other Names:

Refraction by retinoscopy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of test time (minutes) [1-day and within 2 eeks]
How long for each test

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 46 Years

Sexes Eligible for Study:

All

Accepts 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