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- Essai clinique NCT07761949
Assessing the Impact of Streetscape Exposure on Children's Perception
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine
- Recrutement
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Contact:
- Institutional Review Board/Ethics Committee of the Sun Yat-sen
- Numéro de téléphone: +86-20-87330341
- E-mail: Reviewborad_SYsu@163.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Environmental defocus
Délai: First day
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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.
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First day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perception evaluation
Délai: First day
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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.
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First day
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intensity of physical activity
Délai: First day
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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.
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First day
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Axis Length
Délai: First day
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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.
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First day
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Refractive demand at fixation
Délai: First day
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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.
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First day
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Visual acuity
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025KYPJ171-2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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