Longitudinal Measurements of Visual Diet in Children (VEET)
Myopia is a leading cause of visual impairment worldwide, with prevalence rising rapidly among children. Growing evidence suggests that environmental and behavioral factors play a dominant role in ocular growth; however, current studies typically isolate single components of the visual environment, such as near work or light intensity, limiting investigators' understanding of how multiple visual stimuli interact within individuals over time. The retina is continuously exposed to a dynamic "visual diet," encompassing viewing distance, illuminance, spectral composition of light, and temporal viewing patterns, as well as associated visuomotor responses such as eye vergence and pupil dynamics. A critical barrier to myopia prevention is the lack of longitudinal, quantitative measurements that integrate these factors in real-world settings during childhood ocular development.
The long-term goal of this project is to prevent myopia onset and slow myopia progression through individualized, patient-centered monitoring and modification of the visual diet. The overall objective of this proposal is to longitudinally characterize visual diet and visuomotor behavior in children and to identify the most influential environmental and physiological factors driving myopia onset and progression. The investigators will conduct a 3-year longitudinal observational study enrolling 60 children aged 7-12 years, including myopic children and non-myopic children stratified by risk of myopia progression.
調査の概要
詳細な説明
Visual stimulation plays a critical role in guiding eye growth through activity dependent mechanisms. To date, this visual stimulation or visual diet has been investigated by measuring isolated components including near work, light intensity, or wavelength across different individuals. However, this approach does not address how multiple components of the visual diet interact in the visual development of each individual child. Knowledge gap: There is an urgent need for longitudinal measurements from individual children that incorporate multiple components of the visual environment and visual function as the eye grows and develops. This proposal addresses this gap by measuring longitudinally children's visual diet using a combination of techniques that will record these multiple components with VEET (Visual Environment Evaluation Tool, Meta Reality labs), modern eye tracking, refraction, and biometry. The understanding of the interactions between the visual environment and visual function will allow us to develop more effective approaches for myopia prevention and control.
One major reason that visual diets remain under-investigated is the lack of appropriate technology. The investigators propose to use the novel VEET to measure spectral irradiance, illuminance, viewing distance, and head motion. In addition, the investigators propose to use modern wearable eye tracking to quantify visuomotor response during reading. The investigators' long-term goal is to prevent myopia onset and slow myopia progression in children through an individualized, patient-centered approach that monitors and modifies the visual diet. The specific objective of this proposal is to identify what individual features of the visual diet have the strongest impact on myopia development, and provide specific guidelines to monitor and modify them accordingly in an individualized manner.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Xiaoying Zhu, OD, PhD, MD, MS, FAAO
- 電話番号：212-838-5541
- メール：xzhu@sunyopt.edu
研究連絡先のバックアップ
- 名前：Jingyun Wang, PhD, FAAO
- 電話番号：212-938-5759
- メール：jwang@sunyopt.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10036
- 募集
- SUNY College of Optometry
-
コンタクト：
- Xiaoying Zhu
- 電話番号：212-838-5541
- メール：xzhu@sunyopt.edu
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age: 7-12 years old (inclusive)
- Astigmatism of < 1.50D
- Stereopsis equal or better 100 seconds of arc
- Normal binocular functions.
In addition, for the Myopic group:
- Cycloplegic autorefraction (spherical equivalent, SEQ) between -0.50D and -6.00D, who are not currently pursuing nor intending to start myopia control at the time of enrollment.
For the non-myopic group:
- SEQ between plano and +2.50D.
Exclusion Criteria for both groups:
- History of refractive surgery or myopia control
- Binocular abnormalities
- Ocular and systemic pathologies
- Developmental delay
- Unable to wear the VEET at home for 8 days every 6 months for 3 years
- Pre-term birth (< 34 weeks of gestational age).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Myopic group
Children with myopia
|
|
Control
Children without myopia
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Refractive error (D)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured with an autorefractor
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Axial length (mm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured with a biometer
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Viewing distance (cm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured using the Visual Environment Evaluation Tool (VEET). VEET contains multiple time-of-flight (ToF) infrared sensors embedded in the temple arms of the glasses.The sensors emit infrared light toward objects in front of the wearer. The device measures the time required for the reflected infrared light to return to the sensor. Using the speed of light, the system calculates the distance between the eye/glasses and the viewed object. |
From enrollment to the end of the 3-year study, every 6 months
|
|
Illuminance (lux)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured with the Visual Environment Evaluation Tool (VEET).
VEET uses photometric light sensors that detect the light intensity.
The sensors convert incoming light into electrical signals proportional to brightness, and the device reports illuminance in lux, the standard unit for light exposure.
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Wavelength of the environmental light (nm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured with the Visual Environment Evaluation Tool (VEET).
The VEET measures light wavelength using integrated spectral light sensors that analyze the composition of incoming light across different portions of the visible spectrum.
Rather than only measuring brightness (illuminance), the device also characterizes the spectral distribution of light reaching the wearer.
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Eye vergence (degree)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Using an eye tracker (Pupil Labs). Pupil Labs eye trackers measure eye vergence by tracking the gaze direction of both eyes separately and then calculating the angle between the two visual axes. Vergence refers to the inward or outward rotation of the eyes when focusing at different viewing distances: Convergence → eyes rotate inward for near targets Divergence → eyes rotate outward for distant targets Pupil Labs estimates vergence using these steps:
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Pupil size (mm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Using an eye tracker (Pupil Labs).
Eye trackers measure pupil size using infrared video imaging and computer vision algorithms that detect the pupil boundary in images captured by eye-facing cameras.
The eye tracker shines infrared (IR) light onto the eye using tiny IR LEDs.
Infrared light is invisible to the user and produces stable illumination conditions for imaging the pupil.
Small cameras pointed at the eyes continuously record high-speed grayscale images of the eye.
The pupil appears darker than surrounding structures when using the "dark pupil" technique commonly used in wearable eye trackers.
Finally, computer vision algorithms analyze each frame to locate the pupil region, identify the pupil edge, and fit a geometric shape to detect the pupil size in mm.
|
From enrollment to the end of the 3-year study, every 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Height (cm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Using a stadiometer.
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Arm length (cm)
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Measured using a tape measure.
|
From enrollment to the end of the 3-year study, every 6 months
|
|
Accommodative facility
時間枠：From enrollment to the end of the 3-year study, every 6 months
|
Using +/- 2.00 D flippers
|
From enrollment to the end of the 3-year study, every 6 months
|
協力者と研究者
捜査官
- 主任研究者：Xiaoying Zhu, OD, PhD, MD, MS, FAAO、State University of New York College of Optometry
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。