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Undersøgelse af Myopi Progression og blød bifokal kontaktlinse Myopi Control (BLINK2)

6. maj 2026 opdateret af: Jeffrey J. Walline, OD PhD, Ohio State University

Undersøgelse af Myopi Progression og konsekvenser og mekanismer af blød bifokal kontaktlinse Myopi Control

Dette projekt har til hensigt at give vigtige, hidtil uopfyldte svar vedrørende biologiske sammenhænge med progression af nærsynethed for at forbedre evnen til at forudsige patienter, der er mest tilbøjelige til at drage fordel af kontrol med nærsynethed, samt spørgsmål, som ofte stilles af patienter og behandlere vedr. bivirkninger, mekanisme og seponering af blød bifokal kontaktlinse-myopikontrol. De første tre mål undersøger sammenhængen mellem biologiske variabler, der kan måles non-invasivt, og progression af nærsynethed, og de vil blive udført uanset resultatet af det igangværende BLINK-studie. De sidste tre specifikke mål vil blive udført, hvis bløde bifokale kontaktlinser bremsede progressionen af ​​nærsynethed med 30 % eller mere i BLINK-undersøgelsen, og de kan undersøges med meget få yderligere målinger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Det primære mål med BLINK2-undersøgelsen er at bestemme korrelater for progression af nærsynethed ved hjælp af ikke-invasiv måling af biomarkører, såsom choroidal tykkelse og iboende lysfølsom retinal gangliecelle-medieret pupilfunktion og udendørs lyseksponering hos børn. Hvis multifokale kontaktlinser bremser progressionen af ​​nærsynethed med 30 procent eller mere sammenlignet med enkeltsynskontaktlinser under BLINK-studiet, vil efterforskerne også besvare vigtige spørgsmål om konsekvenserne og mekanismen af ​​behandlingseffekten, såsom om multifokal kontaktlinsebrug ændrer sig akkomodativ funktion og hvorvidt behandlingsudbyttet er forbigående. Specifikt vil efterforskerne undersøge, om myopiprogression er langsommere eller blot forsinket af multifokal kontaktlinsebrug, og om der er et tilbageslag i myopiprogression, en stigning i progressionshastighed, efter seponering af multifokale kontaktlinser. Efterforskerne vil identificere nærsynede børn, som vil have størst gavn af kontrol med nærsynethed ved at bestemme dem, der har størst sandsynlighed for at udvikle sig, og derved maksimere potentialet for fordele og minimere risikoen. Efterforskerne vil opnå dette mål ved at undersøge effekten på progression af de vigtigste okulære og miljømæssige risikofaktorer, der for nylig er antaget til at kontrollere øjenvækst. Projektet vil indsamle det mest omfattende longitudinelle datasæt nogensinde om koroidal tykkelse i barndomsnærsynethed. Forskerne vil teste det vigtige spørgsmål om, hvorvidt tid udendørs og lyseksponering påvirker myopiprogression efter debut, ud over om disse påvirkninger er medieret af iboende lysfølsomme retinale ganglieceller. Hvis bløde multifokale kontaktlinser viser en klinisk betydningsfuld opbremsning af nærsynethedsprogression, vil vi også besvare vigtige spørgsmål, som stilles rutinemæssigt af vores kliniske kolleger. Efterforskerne vil kende den akkommodative effekt af flere års multifokal kontaktlinsebrug hos børn, efterforskerne vil vide, om multifokale kontaktlinser forsinker eller blot forsinker myopiprogressionen, og efterforskerne vil vide, om myopiprogressionen stiger efter ophør med brug af bløde multifokale kontaktlinser . Svar på spørgsmål behandlet af dette forslag kan forbedre omsorgen for 60 millioner nærsynede børn i USA. Mens konsekvenserne af almindelig nærsynethed sjældent er synstruende, er livskvaliteten for nærsynede patienter negativt påvirket, og sundhedsudgifterne til behandling af nærsynethed er cirka 4,6 milliarder dollars i 1990 amerikanske dollars. National Eye Institute anerkender behovet for at evaluere effektiviteten af ​​potentielle behandlinger for at forsinke debuten eller for at bremse progressionen af ​​nærsynethed, såsom linser, der ændrer perifer defokus. BLINK2-undersøgelsen søger at maksimere fordelen og samtidig sænke risikoen for multifokal kontaktlinsebrug til kontrol af nærsynethed og samtidig besvare vigtige videnskabelige og kliniske spørgsmål om konsekvenserne og mekanismen for progression af nærsynethed, et problem, der påvirker mange mennesker i USA.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

248

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University
    • Texas
      • Houston, Texas, Forenede Stater, 77204
        • University of Houston

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 15 år (Barn)

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Only those participants in the original BLINK Study who have consented to continue will be enrolled in BLINK2.

Beskrivelse

Inklusionskriterier:

  • Deltagere i BLINK-undersøgelsen

Ekskluderingskriterier:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: Contact lenses
2.50 D multifocal contact lens years 1 and 2. Year 3 all wear a single vision contact lens.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length
Tidsramme: Three years

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
The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length
Tidsramme: Three years

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
The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length
Tidsramme: Three years

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
Three-year Choroidal Thickness Change
Tidsramme: 3 years
The three-year change from baseline to three years for choroidal thickness.
3 years
Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline
Tidsramme: Baseline
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.
Baseline
Baseline iPRGC Activity
Tidsramme: Baseline
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.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accommodative Amplitude
Tidsramme: Baseline
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
Baseline
Lag of Accommodation
Tidsramme: Baseline
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.
Baseline
Accommodative Facility
Tidsramme: Baseline
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.
Baseline
Slowing of Myopia Progression - Axial Length
Tidsramme: Two year change (Baseline 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, 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)
Rebound of Progression - Axial Length
Tidsramme: One year change (2-year visit to 3-year visit)

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)
Rebound of Progression - Myopia Progression
Tidsramme: One year change (2-year visit to 3-year visit)

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)
Slowing of Myopia Progression - Myopia Progression
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ohio State University

Samarbejdspartnere

University of Houston

Efterforskere

  • Ledende efterforsker: Jeffrey J Walline, OD PhD, The Ohio State University College of Optometry

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. september 2019

Primær færdiggørelse (Faktiske)

4. januar 2024

Studieafslutning (Faktiske)

4. januar 2024

Datoer for studieregistrering

Først indsendt

27. august 2019

Først indsendt, der opfyldte QC-kriterier

3. september 2019

Først opslået (Faktiske)

6. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UG1EY023206 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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