- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07761949
Assessing the Impact of Streetscape Exposure on Children's Perception
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Contact:
- Institutional Review Board/Ethics Committee of the Sun Yat-sen
- Phone Number: +86-20-87330341
- Email: Reviewborad_SYsu@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1: Myopia group: (1) informed consent obtained; (2) children aged 6-18 years; (3) no contraindications for wearing the eye-tracker (e.g., high astigmatism, head/neck injury); (4) myopia already present in at least one eye (spherical equivalent ≤ -0.50 D).
2: Emmetropia group: (1) informed consent obtained; (2) children aged 6-18 years; (3) no contraindications for wearing the eye-tracker (e.g., high astigmatism, head/neck injury).
Exclusion Criteria:
- 1: Myopia group: (1) high myopia in either eye (spherical equivalent ≤ -6.00 D); (2) any ocular pathology other than myopia (strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal disease, etc.); (3) systemic disorders that may affect vision or visual development (e.g., diabetes); (4) anisometropia > 1.00 D or astigmatism > 2.00 D in either eye.
2: Emmetropia group: (1) myopia or hyperopia in either eye (spherical equivalent ≤ -0.50 D or ≥ +0.50 D); (2) any ocular pathology (strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal disease, etc.); (3) systemic disorders that may affect vision or visual development (e.g., diabetes); (4) anisometropia > 1.00 D or astigmatism > 2.00 D in either eye.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Myopia group
(1) informed consent obtained; (2) children aged 6-18 years; (3) no contraindications for wearing the eye-tracker (e.g., high astigmatism, head/neck injury); (4) myopia already present in at least one eye (spherical equivalent ≤ -0.50 D).
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Transforming real street scenes into virtual simulation environments, and recreating the visual exposure of actual street scenes in a laboratory setting through wearing VR headsets.
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Emmetropia group
(1) informed consent obtained; (2) children aged 6-18 years; (3) no contraindications for wearing the eye-tracker (e.g., high astigmatism, head/neck injury).
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Transforming real street scenes into virtual simulation environments, and recreating the visual exposure of actual street scenes in a laboratory setting through wearing VR headsets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Environmental defocus
Time Frame: First day
|
The eye movement behaviors of the subjects were measured using the HTC VR helmet and the 7XINiwei aSee Studio, and then calculated by combining with the deep learning algorithm.
|
First day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perception evaluation
Time Frame: First day
|
After the experiment process was completed, the Environmental Perception Questionnaire was used to measure the subjects' psychological perception of the streetscape environment, such as whether it was safe and comfortable.
By comparing the pictures, the option that better matches the description is selected.
The more times a picture is chosen, the safer or more comfortable it is considered.
|
First day
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of physical activity
Time Frame: First day
|
Use the modified GPAQ physical activity questionnaires.
Each question has 5 options, representing scores from 0 to 5. The arithmetic mean score of all the questions represents the activity level of the child.
|
First day
|
|
Axis Length
Time Frame: First day
|
Under natural pupils, axial length was measured with the IOL Master.
One eye was occluded while the fellow eye fixated straight ahead; three readings were taken and averaged.
|
First day
|
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Refractive demand at fixation
Time Frame: First day
|
The eye movement behaviors of the subjects were measured using the HTC VR helmet and the 7XINiwei aSee Studio, and then calculated by combining with the deep learning algorithm.
|
First day
|
|
Visual acuity
Time Frame: First day
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Use the ETDRS visual acuity chart
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First day
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Non-cycloplegic refraction
Time Frame: First day
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Measure using an automatic optometry instrument.
The refractive power measured in the non-ciliary muscle paralysis state is expressed by the equivalent spherical refraction (SER), where SER = spherical refractive power + 1/2 × cylindrical refractive power.
Computer refraction operation standard: Each eye is measured continuously 3 times, and the average value automatically output by the instrument is taken as the final result.
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First day
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025KYPJ171-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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