- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07761949
Assessing the Impact of Streetscape Exposure on Children's Perception
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Guangdong
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Guangzhou, Guangdong, Kina
- Rekrytering
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Kontakt:
- Institutional Review Board/Ethics Committee of the Sun Yat-sen
- Telefonnummer: +86-20-87330341
- E-post: Reviewborad_SYsu@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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).
|
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.
|
|
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).
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Environmental defocus
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perception evaluation
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intensity of physical activity
Tidsram: 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
|
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Axis Length
Tidsram: 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
Tidsram: 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
|
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Visual acuity
Tidsram: First day
|
Use the ETDRS visual acuity chart
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First day
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Non-cycloplegic refraction
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025KYPJ171-2
Plan för individuella deltagardata (IPD)
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