近視進行検査とソフト遠近両用コンタクトレンズ近視コントロール (BLINK2)
近視の進行とソフト遠近両用コンタクトレンズ近視制御の結果とメカニズムの検討
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University
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Texas
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Houston、Texas、アメリカ、77204
- University of Houston
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参加基準
適格基準
就学可能な年齢
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
包含基準:
- BLINK研究の参加者
除外基準:
-
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 |
介入・治療 |
|---|---|
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Contact lens
The first two years of the study all participants will wear +2.50 D multifocal contact lenses.
The last year of the study, all subjects will be wearing single vision contact lenses.
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2.50 D multifocal contact lens years 1 and 2. Year 3 all wear a single vision contact lens.
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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 |
|---|---|---|
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The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length
時間枠：Three years
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test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with the outcome of greater axial elongation (eye growth) The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study. |
Three years
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The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length
時間枠：Three years
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test the hypothesis that less ipRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient) as measured at the Baseline BLINK 2 is associated with greater axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study. |
Three years
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The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length
時間枠：Three years
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test the hypothesis that exposure to light levels over 1000 lux as measured at the Baseline BLINK2 visit is associated with less axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study. |
Three years
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Three-year Choroidal Thickness Change
時間枠：3 years
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The three-year change from baseline to three years for choroidal thickness.
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3 years
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Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline
時間枠：Baseline
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Baseline light exposure as measured by minutes at light levels over 1000 lux.
Light exposure was monitored using the Actiwatch2 (Phillips Respironics), a light-sensing and logging watch worn on the wrist.
Participants wore the device for a 1 week period to monitor environmental light exposure.
The illuminance was measured in lux every minute.
Data were scrubbed of periods where the watch was not worn or other artifacts.
Light levels over 1000 lux were added to determine time outdoors in minutes.
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Baseline
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Baseline iPRGC Activity
時間枠：Baseline
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Baseline iPRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient).
The Blue Decay Coefficient represents the rate at which the pupil redilates in the dark after exposure to multiple 5-second pulses of red and blue light.
The redilation data are fit by an exponential decay function eβt where t is time in seconds and the coefficient β is the natural log of the percent change in pupil diameter per second.
Values range from -0.30 to -0.01.
More positive values represent slower pupil redilation and are associated with greater, potentially beneficial ipRGC activity.
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Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Accommodative Amplitude
時間枠：Baseline
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Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative amplitude.
This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative amplitude will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474).
Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported
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Baseline
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Lag of Accommodation
時間枠：Baseline
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Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative lag.
This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative lag will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474).
Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported.
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Baseline
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Accommodative Facility
時間枠：Baseline
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Testing the hypothesis that long-term soft bifocal contact lens wear does not alter accommodative facility.
This hypothesis predicts that at the baseline BLINK2 Study visit, the accommodative lag will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study (NCT02255474).
Assessed data from the beginning of the BLINK Study up to the BLINK2 Study Baseline Visit approximately 4.7 years, BLINK2 Study Baseline Visit reported.
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Baseline
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Slowing of Myopia Progression - Axial Length
時間枠：Two year change (Baseline to 2-Year visit)
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Test the hypothesis that wearing +2.50 D multifocal contact lenses slow rather than merely delay myopia progression. This null hypothesis predicts that during the first two years of the BLINK2 Study, when all subjects will wear +2.50 D multifocal contact lenses, axial length elongation at the same rate regardless of original lens assignment (i.e., +2.50 D multifocal lenses, +1.50 D multifocal lenses, SVLs). Alternatively, faster myopia progression in subjects originally fitted with soft bifocal contact lenses compared to single vision contact lenses would indicate a delay in myopia progression rather than a permanent treatment benefit. Measured as the change the baseline BLINK2 visit to the 2 year visit on the IOLMaster which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the exposures before the baseline visit were part of NCT02255474 immediately before this cohort, the original groups were analyzed. |
Two year change (Baseline to 2-Year visit)
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Rebound of Progression - Axial Length
時間枠：One year change (2-year visit to 3-year visit)
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The investigators will test the hypothesis that there is no increase in myopia when switching from +2.50 D multifocal contact lenses to single vision contact lenses in Year 2 of the BLINK2 observational study. This hypothesis predicts that the progression of myopia during the last year of follow-up when all subjects will switch to single vision contact lenses, will be similar to myopia progression during the first two years when all subjects wore multifocal contact lenses. Alternatively, faster progression after switching to single vision contact lens wear indicates a "rebound" of myopia progression. This aim was specifically designed to measure what happened between the 2nd and 3rd annual visit which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the entire cohort was wearing the same contact lens, it uses all participants together. |
One year change (2-year visit to 3-year visit)
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Rebound of Progression - Myopia Progression
時間枠：One year change (2-year visit to 3-year visit)
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The investigators will test the hypothesis that there is no increase in myopia, as measured by the change in the spherical equivalent, when switching from +2.50 D multifocal contact lenses to single vision contact lenses in Year 2 of the BLINK2 observational study. This hypothesis predicts that the progression of myopia during the last year of follow-up when all subjects will switch to single vision contact lenses, will be similar to myopia progression during the first two years when all subjects wore multifocal contact lenses. Alternatively, faster progression after switching to single vision contact lens wear indicates a "rebound" of myopia progression. This aim was specifically designed to measure what happened between the 2nd and 3rd annual visit which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the entire cohort was wearing the same contact lens, it uses all participants together. |
One year change (2-year visit to 3-year visit)
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Slowing of Myopia Progression - Myopia Progression
時間枠：Two year change (Baseline visit to 2-year visit)
|
Test the hypothesis that wearing +2.50 D multifocal contact lenses slow rather than merely delay myopia progression. This null hypothesis predicts that during the first two years of the BLINK2 Study, when all subjects will wear +2.50 D multifocal contact lenses, participants will have myopia progression, as measured by spherical equivalent, at the same rate regardless of original lens assignment (i.e., +2.50 D multifocal lenses, +1.50 D multifocal lenses, SVLs). Alternatively, faster myopia progression in those with soft bifocal contact lenses compared to SVLs would indicate a delay in myopia progression rather than a permanent treatment benefit. Measured between Baseline and Year 2 of the BLINK2 Study which is not the entire time frame of the study - as detailed in the specific aims from the funded grant proposal. Because the exposures before the baseline visit were part of NCT02255474 immediately before this cohort, the original groups were analyzed. |
Two year change (Baseline visit to 2-year visit)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jeffrey J Walline, OD PhD、The Ohio State University College of Optometry
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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