근시 진행 및 소프트 이중초점 콘택트렌즈 근시 조절 검사 (BLINK2)
소프트 이중초점 콘택트렌즈의 근시 진행과 결과 및 기전 고찰 원문보기 KCI 원문보기 인용
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University
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Texas
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Houston, Texas, 미국, 77204
- University of Houston
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
포함 기준:
- BLINK 연구 참가자
제외 기준:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Accommodative Amplitude
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Two year change (Baseline visit 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, 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeffrey J Walline, OD PhD, The Ohio State University College of Optometry
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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