- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07761949
Assessing the Impact of Streetscape Exposure on Children's Perception
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국
- 모병
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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연락하다:
- Institutional Review Board/Ethics Committee of the Sun Yat-sen
- 전화번호: +86-20-87330341
- 이메일: Reviewborad_SYsu@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Environmental defocus
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perception evaluation
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intensity of physical activity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025KYPJ171-2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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