- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07761949
Assessing the Impact of Streetscape Exposure on Children's Perception
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Guangdong
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Guangzhou, Guangdong, China
- Rekrutierung
- 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-Mail: Reviewborad_SYsu@163.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Environmental defocus
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Perception evaluation
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Intensity of physical activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025KYPJ171-2
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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