NCT06059521

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
57mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jul 2023Dec 2030

Study Start

First participant enrolled

July 15, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Expected
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

July 24, 2023

Last Update Submit

September 21, 2023

Conditions

MyopiaMyopia, ModerateAstigmatism

Keywords

softwarerefractionsubjective refractionmobileronemyopiaastigmatism

Outcome Measures

Primary Outcomes (4)

  • Spherical Equivalence(D)

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

    1-day and within 2 weeks

  • Astigmatism Power(D)

    Cylinder value of each total astigmatism power

    1-day and within 2 weeks

  • Astigmatism axial

    Cylinder axis of astigmatism

    1-day and within 2 weeks

  • pupil distance (mm)

    pupil distance measurement with software or autorefractor

    1-day and within 2 weeks

Secondary Outcomes (1)

  • Efficacy of test time (minutes)

    1-day and within 2 eeks

Study Arms (2)

Software Refraction

EXPERIMENTAL

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

Device: Software refraction with Eye Test Technology in a mobilerone

Refraction by retinoscopy

ACTIVE COMPARATOR

Refraction is done objectively by retinoscopy.

Device: Retinoscopy

Interventions

Software refraction with Eye Test Technology in a mobileroneDEVICE

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

Also known as: Online refraction or App refraction with Eye Test Technology
Software Refraction
RetinoscopyDEVICE

Retinoscopy is an objective refraction method with retinoscope.

Also known as: Refraction by retinoscopy
Refraction by retinoscopy

Eligibility Criteria

Age10 Years - 46 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Airdoc MPC Opthalmology Clinics

Beijing, Beijing Municipality, 100089, China

NOT YET RECRUITING

Jenny QIU

Beijing, Beijing Municipality, 100089, China

RECRUITING

Qiu Jenny

Beijing, Haidian District, 100089, China

RECRUITING

MeSH Terms

Conditions

MyopiaLymphoma, FollicularAstigmatism

Interventions

Retinoscopy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OphthalmoscopyDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

September 28, 2023

Study Start

July 15, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2030

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)