Actively Recruiting
Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
Led by Beijing Airdoc Technology Co., Ltd. · Updated on 2023-09-28
120
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
Sponsors
B
Beijing Airdoc Technology Co., Ltd.
Lead Sponsor
U
University of Notre Dame Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates a new software refraction technology installed on a mobilerone device, designed to measure myopic refractive errors with or without astigmatism in adults and older children. Researchers aim to test the accuracy, effectiveness, and safety of this software compared to the traditional retinoscopy method. This study is a randomized controlled trial to compare the two refraction methods in participants with myopia or astigmatism. Participants are randomly assigned to one of two groups. One group uses the software refraction app on the mobilerone device, which provides subjective guidance on screen during the test. The other group undergoes objective refraction using retinoscopy with a retinoscope. Both methods are evaluated for their refractive results, including spherical equivalence, astigmatism power, astigmatism axis, and pupil distance. During the study, participants will have their refraction measured at the start and within two weeks. Researchers will also track the time taken to complete each test. Participants need to cooperate with the screening and operators, and assessments include vision acuity checks and eye health evaluations. The trial includes adults and older children aged 10 to 46 years, with follow-up visits scheduled to assess the primary outcomes related to refraction accuracy and test efficiency.
CONDITIONS
Brief Title
Software Refraction With Mobilerone Versus Retinoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject with ametropia on each eye less than or equal to -12.00 diopters
- Best corrected visual acuity of at least 20/25 with no amblyopia
- Normal transparency of eyes
- Healthy fundus without major abnormalities affecting vision
- Ability to cooperate with the screening and operator
- No heavy drug treatment affecting vision such as synthetic antimalarials or corticosteroids
- Non-diabetic
- No nystagmus
- No strabismus
- No eye surgery within the past year
You will not qualify if you...
- Anomaly on topography such as keratoconus or similar
- Presence of hyperopia or presbyopia
- Mild myopia greater than or equal to -1.00 diopters
- Inability to communicate with the operator, including some optometrists or ophthalmologists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo refraction testing using either the software installed on a mobilerone or retinoscopy to assess myopic refractive error.
1 visit (in-person)
Duration - Within 2 weeks
Participants are monitored to compare refraction results and measure outcomes such as spherical equivalence, astigmatism power, astigmatism axial, and pupil distance over a period following the initial test.
1 follow-up visit (in-person)
Trial Site Locations
Total: 3 locations
1
Airdoc MPC Opthalmology Clinics
Beijing, Beijing Municipality, China, 100089
Not Yet Recruiting
2
Jenny QIU
Beijing, Beijing Municipality, China, 100089
Actively Recruiting
3
Qiu Jenny
Beijing, Haidian District, China, 100089
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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