Software Refraction With Mobilerone Versus Retinoscopy (SRMR)

September 21, 2023 updated by: Beijing Airdoc Technology Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100089
        • Not yet recruiting
        • Airdoc MPC Opthalmology Clinics
        • Contact:
      • Beijing, Beijing, China, 100089
    • Haidian District
      • Beijing, Haidian District, China, 100089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of test time (minutes)
Time Frame: 1-day and within 2 eeks
How long for each test
1-day and within 2 eeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Airdoc Technology Co., Ltd.

Collaborators

University of Notre Dame Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AirdocSoftwareEyeTest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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