Software Refraction With Mobilerone Versus Retinoscopy

Myopia Clinical Trial

— SRMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059521
• Other study ID #: AirdocSoftwareEyeTest
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: December 30, 2030

Study information

• Verified date: September 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Software refraction with Eye Test Technology in a mobilerone
Refraction is done by software App by a mobilerone software installed.
• Retinoscopy
Retinoscopy is an objective refraction method with retinoscope.

Locations

Country	Name	City	State
China	Airdoc MPC Opthalmology Clinics	Beijing	Beijing
China	Jenny QIU	Beijing	Beijing
China	Qiu Jenny	Beijing	Haidian District

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.	University of Notre Dame Australia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Equivalence(D)	Spherical is myopic equivalence with total spherical plus half the cylinder diopter.	1-day and within 2 weeks
Primary	Astigmatism Power(D)	Cylinder value of each total astigmatism power	1-day and within 2 weeks
Primary	Astigmatism axial	Cylinder axis of astigmatism	1-day and within 2 weeks
Primary	pupil distance (mm)	pupil distance measurement with software or autorefractor	1-day and within 2 weeks
Secondary	Efficacy of test time (minutes)	How long for each test	1-day and within 2 eeks