Software Refraction With Mobilerone Versus Retinoscopy

Not Applicable

Recruiting

• Conditions: Myopia, Moderate; Astigmatism; Myopia
• Interventions: Device: Software refraction with Eye Test Technology in a mobilerone; Device: Retinoscopy

• Registration Number: NCT06059521
• Lead Sponsor: Beijing Airdoc Technology Co., Ltd.

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.

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 Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2023-07-24
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-12-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Software Refraction	Software refraction with Eye Test Technology in a mobilerone	Refraction is done by software with subjective refraction through a mobilerone.
Refraction by retinoscopy	Retinoscopy	Refraction is done objectively by retinoscopy.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Efficacy of test time (minutes)	1-day and within 2 eeks	How long for each test

Trial Locations

Locations (3)

Jenny QIU; 🇨🇳 Beijing, Beijing, China

Airdoc MPC Opthalmology Clinics; 🇨🇳 Beijing, Beijing, China

Qiu Jenny; 🇨🇳 Beijing, Haidian District, China