Back to resultsSoftware Refraction With Mobilerone Versus Retinoscopy (SRMR)
Primary Purpose
Myopia, Myopia, Moderate, Astigmatism
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Software refraction with Eye Test Technology in a mobilerone
Retinoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Myopia focused on measuring software, refraction, subjective refraction, mobilerone, myopia, astigmatism
Eligibility Criteria
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
Sites / Locations
- Airdoc MPC Opthalmology Clinics
- Jenny QIURecruiting
- Qiu JennyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Software Refraction
Refraction by retinoscopy
Arm Description
Refraction is done by software with subjective refraction through a mobilerone.
Refraction is done objectively by retinoscopy.
Outcomes
Primary Outcome Measures
Spherical Equivalence(D)
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Astigmatism Power(D)
Cylinder value of each total astigmatism power
Astigmatism axial
Cylinder axis of astigmatism
pupil distance (mm)
pupil distance measurement with software or autorefractor
Secondary Outcome Measures
Efficacy of test time (minutes)
How long for each test
Full Information
NCT ID
NCT06059521
First Posted
July 24, 2023
Last Updated
September 21, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
University of Notre Dame Australia
1. Study Identification
Unique Protocol Identification Number
NCT06059521
Brief Title
Software Refraction With Mobilerone Versus Retinoscopy
Acronym
SRMR
Official Title
Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
University of Notre Dame Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Myopia, Moderate, Astigmatism
Keywords
software, refraction, subjective refraction, mobilerone, myopia, astigmatism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Software Refraction
Arm Type
Experimental
Arm Description
Refraction is done by software with subjective refraction through a mobilerone.
Arm Title
Refraction by retinoscopy
Arm Type
Active Comparator
Arm Description
Refraction is done objectively by retinoscopy.
Intervention Type
Device
Intervention Name(s)
Software refraction with Eye Test Technology in a mobilerone
Other Intervention Name(s)
Online refraction or App refraction with Eye Test Technology
Intervention Description
Refraction is done by software App by a mobilerone software installed.
Intervention Type
Device
Intervention Name(s)
Retinoscopy
Other Intervention Name(s)
Refraction by retinoscopy
Intervention Description
Retinoscopy is an objective refraction method with retinoscope.
Primary Outcome Measure Information:
Title
Spherical Equivalence(D)
Description
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Time Frame
1-day and within 2 weeks
Title
Astigmatism Power(D)
Description
Cylinder value of each total astigmatism power
Time Frame
1-day and within 2 weeks
Title
Astigmatism axial
Description
Cylinder axis of astigmatism
Time Frame
1-day and within 2 weeks
Title
pupil distance (mm)
Description
pupil distance measurement with software or autorefractor
Time Frame
1-day and within 2 weeks
Secondary Outcome Measure Information:
Title
Efficacy of test time (minutes)
Description
How long for each test
Time Frame
1-day and within 2 eeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Airdoc MPC Opthalmology Clinics
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David, OD
Phone
+8618510386815
Email
davidcoveney69@gmail.com
Facility Name
Jenny QIU
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny QIU, MD
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com
Facility Name
Qiu Jenny
City
Beijing
State/Province
Haidian District
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QIU JENNY, MD
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Software Refraction With Mobilerone Versus Retinoscopy
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