Software Refraction With Mobilerone Versus Retinoscopy

NCT ID: NCT06059521

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2030-12-30

Brief Summary

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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

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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.

Conditions

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Myopia Myopia, Moderate Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Software Refraction

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

Group Type EXPERIMENTAL

Software refraction with Eye Test Technology in a mobilerone

Intervention Type DEVICE

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

Refraction by retinoscopy

Refraction is done objectively by retinoscopy.

Group Type ACTIVE_COMPARATOR

Retinoscopy

Intervention Type DEVICE

Retinoscopy is an objective refraction method with retinoscope.

Interventions

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Software refraction with Eye Test Technology in a mobilerone

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

Intervention Type DEVICE

Retinoscopy

Retinoscopy is an objective refraction method with retinoscope.

Intervention Type DEVICE

Other Intervention Names

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Online refraction or App refraction with Eye Test Technology Refraction by retinoscopy

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Notre Dame Australia

OTHER

Sponsor Role collaborator

Beijing Airdoc Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Airdoc MPC Opthalmology Clinics

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Jenny QIU

Beijing, Beijing Municipality, China

Site Status RECRUITING

Qiu Jenny

Beijing, Haidian District, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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David, OD

Role: primary

+8618510386815

Jenny QIU, MD

Role: primary

+8618510386815

QIU JENNY, MD

Role: primary

+8618510386815

Other Identifiers

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AirdocSoftwareEyeTest

Identifier Type: -

Identifier Source: org_study_id

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