Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control (BLINK2)
Primary Purpose
Myopia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Participants in the BLINK Study
Exclusion Criteria:
-
Sites / Locations
- Ohio State University
- University of Houston
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Contact lens
Arm Description
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.
Outcomes
Primary Outcome Measures
The statistical correlation between choroidal thickness and axial length
test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with greater axial elongation (eye growth)
The statistical correlation between iPRGC activity and axial length
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)
The statistical correlation between Light levels and axial length
test the hypothesis that exposure to lower light levels is associated with greater axial elongation (eye growth)
Secondary Outcome Measures
Accommodative amplitude
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Lag of accommodation
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Accommodative facility
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Slowing of myopia progression
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Rebound of progression
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Full Information
NCT ID
NCT04080128
First Posted
August 27, 2019
Last Updated
August 23, 2023
Sponsor
Ohio State University
Collaborators
University of Houston
1. Study Identification
Unique Protocol Identification Number
NCT04080128
Brief Title
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
Acronym
BLINK2
Official Title
Examination of Myopia Progression and Consequences and Mechanisms of Soft Bifocal Contact Lens Myopia Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project intends to provide important, previously unmet answers regarding biological associations with myopia (nearsightedness) progression in order to improve the 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.
Detailed Description
The primary goal of the BLINK2 Study is to determine correlates of myopia progression using non-invasive measurement of biomarkers, such as choroidal thickness and intrinsically photosensitive retinal ganglion cell-mediated pupil function, and outdoor light exposure in children. If multifocal contact lenses slow the progression of myopia by 30 percent or more compared to single vision contact lenses during the BLINK Study, the investigators will also answer important questions about the consequences and mechanism of the treatment effect, such as whether multifocal contact lens wear alters accommodative function and whether or not the treatment benefit is transient. Specifically, the investigators will investigate whether myopia progression is slowed or simply delayed by multifocal contact lens wear and whether there is a rebound in myopia progression, an increase in progression rate, after discontinuation of multifocal contact lenses. The investigators will identify myopic children who will most benefit from myopia control by determining those who are most likely to progress, thereby maximizing the potential for benefit and minimizing risk. The investigators will accomplish this goal by investigating the effect on progression of the most important ocular and environmental risk factors recently hypothesized to control eye growth. The project will collect the most extensive longitudinal dataset ever on choroidal thickness in childhood myopia. The investigators will test the important question of whether time outdoors and light exposure influence myopia progression after onset in addition to whether these affects are mediated by intrinsically photosensitive retinal ganglion cells. If soft multifocal contact lenses show a clinically meaningful slowing of myopia progression, we will also answer important questions asked routinely by our clinical colleagues. The investigators will know the accommodative effect of multiple years of multifocal contact lens wear in children, the investigators will know if multifocal contact lenses slow or simply delay myopia progression, and the investigators will know whether myopia progression increases following discontinuation of soft multifocal contact lens wear. Answers to questions addressed by this proposal could improve care for 60 million myopic children in the United States. While the consequences of ordinary myopia are rarely sight-threatening, the quality of life for myopic patients is negatively affected and the health care costs to treat myopia are approximately 4.6 billion dollars in 1990 US dollars. The National Eye Institute recognizes the need to evaluate the efficacy of potential treatments for delaying the onset or for slowing the progression of myopia, such as lenses that alter peripheral defocus. The BLINK2 Study seeks to maximize benefit while lowering the risk of multifocal contact lens wear for myopia control while answering important scientific and clinical questions about the consequences and mechanism of myopia progression, a problem that affects many people in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contact lens
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Contact lenses
Intervention Description
Depending on the results of the BLINK Study either a single vision spherical contact lens or a multifocal contact lens.
Primary Outcome Measure Information:
Title
The statistical correlation between choroidal thickness and axial length
Description
test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with greater axial elongation (eye growth)
Time Frame
Three years
Title
The statistical correlation between iPRGC activity and axial length
Description
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)
Time Frame
Three years
Title
The statistical correlation between Light levels and axial length
Description
test the hypothesis that exposure to lower light levels is associated with greater axial elongation (eye growth)
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Accommodative amplitude
Description
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Time Frame
Two years
Title
Lag of accommodation
Description
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Time Frame
Two years
Title
Accommodative facility
Description
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Time Frame
Two years
Title
Slowing of myopia progression
Description
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Time Frame
Two years
Title
Rebound of progression
Description
In the event of an effect of multifocal contact lens on myopia progression, the investigators 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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants in the BLINK Study
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Walline, OD PhD
Organizational Affiliation
The Ohio State University College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
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