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NCT Number: NCT06059521

Software Refraction With Mobilerone 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.

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Key information

Age range

10 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Airdoc MPC Opthalmology Clinics, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Software refraction with Eye Test Technology in a mobilerone

Device

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

Other names: Online refraction or App refraction with Eye Test Technology

Retinoscopy

Device

Retinoscopy is an objective refraction method with retinoscope.

Other names: Refraction by retinoscopy

Primary outcomes

  1. Spherical Equivalence(D)

    Time frame: 1-day and within 2 weeks

    Spherical is myopic equivalence with total spherical plus half the cylinder diopter.

  2. Astigmatism Power(D)

    Time frame: 1-day and within 2 weeks

    Cylinder value of each total astigmatism power

  3. Astigmatism axial

    Time frame: 1-day and within 2 weeks

    Cylinder axis of astigmatism

  4. pupil distance (mm)

    Time frame: 1-day and within 2 weeks

    pupil distance measurement with software or autorefractor

Secondary outcomes

  1. Efficacy of test time (minutes)

    Time frame: 1-day and within 2 eeks

    How long for each test

Sponsors and collaborators

Lead sponsor

Beijing Airdoc Technology Co., Ltd.

Industry

Collaborators

  • University of Notre Dame Australia

Registry information

Official study title

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

Acronym: SRMR

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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