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Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control (BLINK2)

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ClinicalTrials.gov Identifier: NCT04080128
Recruitment Status : Enrolling by invitation
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
University of Houston
Information provided by (Responsible Party):
Jeffrey J. Walline, OD PhD, Ohio State University

Brief Summary:
This project intends to provide important, previously unmet answers regarding biological associations with myopia (nearsightedness) progression in order to improve our ability to predict patients who are most likely to benefit from myopia control, as well as questions frequently posed by patients and practitioners about the side effects, mechanism, and discontinuation of soft bifocal contact lens myopia control. The first three aims examine the association between biological variables that can be measured non-invasively and myopia progression, and they will be conducted regardless of the outcome of the currently in progress BLINK Study. The last three specific aims will be conducted if soft bifocal contact lenses slowed myopia progression by 30% or more in the BLINK Study, and they can be investigated with very few additional measurements.

Condition or disease Intervention/treatment Phase
Myopia Device: Contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examination of Myopia Progression and Consequences and Mechanisms of Soft Bifocal Contact Lens Myopia Control
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Contact lens
Depending upon the study lens proven to be the most effective in the BLINK Study, this contact lens will be used for the first two years of the study. The last year of the study, all subjects will be wearing single vision contact lenses.
Device: Contact lenses
Depending on the results of the BLINK Study either a single vision spherical contact lens or a multifocal contact lens.




Primary Outcome Measures :
  1. The statistical correlation between choroidal thickness and axial length [ Time Frame: Three years ]
    test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with greater axial elongation (eye growth)

  2. The statistical correlation between iPRGC activity and axial length [ Time Frame: 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) is associated with greater axial elongation (eye growth)

  3. The statistical correlation between Light levels and axial length [ Time Frame: Three years ]
    test the hypothesis that exposure to lower light levels is associated with greater axial elongation (eye growth)


Secondary Outcome Measures :
  1. Accommodative amplitude [ Time Frame: Two years ]
    In the event of an effect of multifocal contact lens on myopia progression, we will test 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; if they are not similar, they will become similar over the next two years.

  2. Lag of accommodation [ Time Frame: Two years ]
    In the event of an effect of multifocal contact lens on myopia progression, we will test 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, accommodative lag will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study; if they are not similar, they will become similar over the next two years.

  3. Accommodative facility [ Time Frame: Two years ]
    In the event of an effect of multifocal contact lens on myopia progression, we will test 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 facility will be similar across the three treatment groups that were randomly assigned at the beginning of the BLINK Study; if they are not similar, they will become similar over the next two years.

  4. Slowing of myopia progression [ Time Frame: Two years ]
    In the event of an effect of multifocal contact lens on myopia progression, we will test the hypothesis that soft bifocal contact lenses slow rather than merely delay myopia progression. This hypothesis predicts that during the first two years of the BLINK2 Study, when all subjects will wear soft bifocal contact lenses, subjects will progress at the same rate regardless of original lens assignment in the BLINK Study. 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.

  5. Rebound of progression [ Time Frame: One year ]
    In the event of an effect of multifocal contact lens on myopia progression, we will test the hypothesis that there is no increase in myopia when switching from bifocal to single vision contact lenses. 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 bifocal contact lenses. Alternatively, faster progression after switching to single vision contact lens wear indicates a "rebound" of myopia progression.



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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in the BLINK Study

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080128


Locations
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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
Ohio State University
University of Houston
Investigators
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Principal Investigator: Jeffrey J Walline, OD PhD The Ohio State University College of Optometry

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Responsible Party: Jeffrey J. Walline, OD PhD, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT04080128     History of Changes
Other Study ID Numbers: UG1EY023206 ( U.S. NIH Grant/Contract )
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases