Refractive Errors
Conditions
Keywords
pediatrics, refractive error - myopia, contact lenses, intervention
Brief summary
This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.
Detailed description
The primary goal of this project is to determine whether a commercially available soft bifocal contact lens with a distance-center design can slow myopia progression in children. Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel use for a standard contact lens that may keep children from becoming as nearsighted as they would otherwise. Secondary goals are to determine whether the amount of myopic defocus imposed on the peripheral retina by soft bifocal contact lenses is associated in a dose-dependent manner with slowed myopic progression and to determine whether peripheral myopic blur acts to slow eye growth locally or globally. These important pieces of information will enable investigators to learn about the role of peripheral optics for regulating eye growth, which could ultimately lead to optimization of optical signals to slow myopia progression. Ultimately, the information could be used to design optical devices to prevent the onset of myopia in young children. Slowing myopia progression or eventually preventing myopia onset could potentially affect approximately 60 million children in the United States alone. While the consequences of myopia are rarely sight-threatening, the quality of life for myopic patients is negatively affected and the health care costs to treat myopia are astronomical (approximately $4.6 billion in 1990). 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. Using a common treatment of myopia (contact lenses) to potentially slow myopia progression and to learn about optical signals that regulate eye growth is a very novel approach to solving a problem that affects a large proportion of people in the United States.
Interventions
DEVICEBiofinity Multifocal D +1.50 add
This is a monthly disposable contact lens commercially available from CooperVision
DEVICEBiofinity Multifocal D +2.50 add
This is a monthly disposable contact lens commercially available from CooperVision
DEVICEBiofinity
This is a monthly disposable spherical contact lens commercially available from CooperVision
Sponsors
University of Houston
National Eye Institute (NEI)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* 7 to 11 years, inclusive, at baseline examination * -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction * ≤1.00 DC, cycloplegic autorefraction * ≥ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction * 0.1 logMAR or better best-corrected visual acuity in each eye * 0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens * +2.50 D add lens provides adequate fit with respect to movement and centration
Exclusion criteria
* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) * Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.) * Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear) * Previous or current participation in myopia control studies * Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases * Issues that may interfere with the ability to participate over the next 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive Error Progression | 3 years | Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Shape Change and Eye Growth | 3 years | The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus). |
| Association of Peripheral Defocus to Myopic Progression | 3 years | Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only). |
| Axial Length Progression | 3 years | Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Single vision soft contact lens | 98 |
| Biofinity +1.50 D Add Medium add soft bifocal contact lens (+1.50 Diopter add) | 98 |
| Biofinity +2.50 D Add High add soft bifocal contact lens (+2.50 Diopter add) | 98 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Biofinity +1.50 D Add | Total | Biofinity +2.50 D Add | Biofinity |
|---|---|---|---|---|
| Age, Categorical <=18 years | 98 Participants | 294 Participants | 98 Participants | 98 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.3 years STANDARD_DEVIATION 1.2 | 10.3 years STANDARD_DEVIATION 1.2 | 10.36 years STANDARD_DEVIATION 1.2 | 10.3 years STANDARD_DEVIATION 1.1 |
| Age, Customized Age 10 to 11 years | 59 Participants | 177 Participants | 59 Participants | 59 Participants |
| Age, Customized Age 7 to 9 years | 39 Participants | 117 Participants | 39 Participants | 39 Participants |
| Axial length | 24.57 mm STANDARD_DEVIATION 0.85 | 24.48 mm STANDARD_DEVIATION 0.81 | 24.43 mm STANDARD_DEVIATION 0.74 | 24.45 mm STANDARD_DEVIATION 0.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 77 Participants | 26 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 214 Participants | 71 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Peripheral axial length 20 degree inferior | 24.37 mm STANDARD_DEVIATION 0.85 | 24.29 mm STANDARD_DEVIATION 0.81 | 24.24 mm STANDARD_DEVIATION 0.74 | 24.27 mm STANDARD_DEVIATION 0.83 |
| Peripheral axial length 20 degree nasal | 24.31 mm STANDARD_DEVIATION 0.95 | 24.20 mm STANDARD_DEVIATION 0.88 | 24.15 mm STANDARD_DEVIATION 0.86 | 24.16 mm STANDARD_DEVIATION 0.85 |
| Peripheral axial length 20 degree superior | 24.45 mm STANDARD_DEVIATION 0.85 | 24.40 mm STANDARD_DEVIATION 0.82 | 24.36 mm STANDARD_DEVIATION 0.79 | 24.38 mm STANDARD_DEVIATION 0.84 |
| Peripheral axial length 20 degree temporal | 24.20 mm STANDARD_DEVIATION 0.84 | 24.11 mm STANDARD_DEVIATION 0.81 | 24.06 mm STANDARD_DEVIATION 0.74 | 24.07 mm STANDARD_DEVIATION 0.85 |
| Peripheral axial length 30 degree inferior | 24.13 mm STANDARD_DEVIATION 0.82 | 24.06 mm STANDARD_DEVIATION 0.78 | 24.01 mm STANDARD_DEVIATION 0.72 | 24.03 mm STANDARD_DEVIATION 0.81 |
| Peripheral axial length 30 degree nasal | 24.22 mm STANDARD_DEVIATION 0.87 | 24.13 mm STANDARD_DEVIATION 0.84 | 24.07 mm STANDARD_DEVIATION 0.79 | 24.08 mm STANDARD_DEVIATION 0.85 |
| Peripheral axial length 30 degree superior | 24.25 mm STANDARD_DEVIATION 0.86 | 24.21 mm STANDARD_DEVIATION 0.84 | 24.19 mm STANDARD_DEVIATION 0.8 | 24.20 mm STANDARD_DEVIATION 0.86 |
| Peripheral axial length 30 degree temporal | 23.82 mm STANDARD_DEVIATION 0.8 | 23.73 mm STANDARD_DEVIATION 0.79 | 23.69 mm STANDARD_DEVIATION 0.73 | 23.69 mm STANDARD_DEVIATION 0.82 |
| Peripheral defocus 20 degree nasal | -0.10 Diopters STANDARD_DEVIATION 0.77 | 0.02 Diopters STANDARD_DEVIATION 0.86 | -0.37 Diopters STANDARD_DEVIATION 0.75 | 0.54 Diopters STANDARD_DEVIATION 0.81 |
| Peripheral defocus 20 degree temporal | -0.27 Diopters STANDARD_DEVIATION 0.79 | -0.19 Diopters STANDARD_DEVIATION 0.96 | -0.86 Diopters STANDARD_DEVIATION 0.74 | 0.56 Diopters STANDARD_DEVIATION 0.75 |
| Peripheral defocus 30 degree nasal | 0.16 Diopters STANDARD_DEVIATION 1.02 | 0.28 Diopters STANDARD_DEVIATION 1.1 | -0.37 Diopters STANDARD_DEVIATION 0.95 | 1.06 Diopters STANDARD_DEVIATION 0.84 |
| Peripheral defocus 30 degree temporal | 0.27 Diopters STANDARD_DEVIATION 1.07 | 0.40 Diopters STANDARD_DEVIATION 1.3 | -0.35 Diopters STANDARD_DEVIATION 1.21 | 1.29 Diopters STANDARD_DEVIATION 1.06 |
| Peripheral defocus 40 degree nasal | 1.07 Diopters STANDARD_DEVIATION 1.3 | 1.23 Diopters STANDARD_DEVIATION 1.42 | 0.44 Diopters STANDARD_DEVIATION 1.23 | 2.17 Diopters STANDARD_DEVIATION 1.17 |
| Peripheral defocus 40 degree temporal | 1.33 Diopters STANDARD_DEVIATION 1.71 | 1.37 Diopters STANDARD_DEVIATION 1.72 | 0.87 Diopters STANDARD_DEVIATION 1.64 | 1.92 Diopters STANDARD_DEVIATION 1.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 25 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 29 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 31 Participants | 13 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 75 Participants | 200 Participants | 66 Participants | 59 Participants |
| Region of Enrollment United States | 98 participants | 294 participants | 98 participants | 98 participants |
| Sex: Female, Male Female | 49 Participants | 177 Participants | 64 Participants | 64 Participants |
| Sex: Female, Male Male | 49 Participants | 117 Participants | 34 Participants | 34 Participants |
| Site Columbus, OH | 48 Participants | 143 Participants | 46 Participants | 49 Participants |
| Site Houston, TX | 50 Participants | 151 Participants | 52 Participants | 49 Participants |
| Spherical equivalent | -2.43 Diopters STANDARD_DEVIATION 1.11 | -2.39 Diopters STANDARD_DEVIATION 1 | -2.28 Diopters STANDARD_DEVIATION 0.9 | -2.46 Diopters STANDARD_DEVIATION 0.97 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 98 | 0 / 98 |
| other Total, other adverse events | 72 / 97 | 71 / 98 | 75 / 97 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 | 0 / 98 |
Outcome results
Primary
Refractive Error Progression
Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity | Refractive Error Progression | -3.46 Diopters | Standard Deviation 1.2 |
| Biofinity +1.50 D Add | Refractive Error Progression | -3.32 Diopters | Standard Deviation 1.48 |
| Biofinity +2.50 D Add | Refractive Error Progression | -2.84 Diopters | Standard Deviation 1.22 |
Comparison: Both eyes used in analysis adjusting for correlation.p-value: <0.01Mixed Models Analysis
Secondary
Association of Peripheral Defocus to Myopic Progression
Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).
Time frame: 3 years
Population: outcome is three-year change in refractive error as a function of baseline peripheral defocus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity | Association of Peripheral Defocus to Myopic Progression | -1.01 Diopters | Standard Deviation 0.66 |
| Biofinity +1.50 D Add | Association of Peripheral Defocus to Myopic Progression | -0.85 Diopters | Standard Deviation 0.82 |
| Biofinity +2.50 D Add | Association of Peripheral Defocus to Myopic Progression | -0.56 Diopters | Standard Deviation 0.66 |
Comparison: This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in placep-value: 0.05Regression, Linear
Secondary
Axial Length Progression
Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity | Axial Length Progression | 25.08 mm | Standard Deviation 0.85 |
| Biofinity +1.50 D Add | Axial Length Progression | 25.12 mm | Standard Deviation 0.97 |
| Biofinity +2.50 D Add | Axial Length Progression | 24.81 mm | Standard Deviation 0.83 |
Comparison: Both eyes used in the analysis controlling for the correlation.p-value: 0.05Mixed Models Analysis
Secondary
Ocular Shape Change and Eye Growth
The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).
Time frame: 3 years
Population: Analysis of peripheral eye length changes with treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Ocular Shape Change and Eye Growth | 30 degree nasal | 24.70 mm | Standard Deviation 0.84 |
| Biofinity | Ocular Shape Change and Eye Growth | 20 degree inferior | 24.92 mm | Standard Deviation 0.85 |
| Biofinity | Ocular Shape Change and Eye Growth | 30 degree superior | 24.76 mm | Standard Deviation 0.92 |
| Biofinity | Ocular Shape Change and Eye Growth | 20 degree superior | 24.98 mm | Standard Deviation 0.89 |
| Biofinity | Ocular Shape Change and Eye Growth | 20 degree nasal | 24.86 mm | Standard Deviation 0.87 |
| Biofinity | Ocular Shape Change and Eye Growth | 20 degree temporal | 24.98 mm | Standard Deviation 0.89 |
| Biofinity | Ocular Shape Change and Eye Growth | 30 degree inferior | 24.64 mm | Standard Deviation 0.83 |
| Biofinity | Ocular Shape Change and Eye Growth | 30 degree temporal | 24.30 mm | Standard Deviation 0.82 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 20 degree superior | 24.98 mm | Standard Deviation 0.97 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 30 degree nasal | 24.79 mm | Standard Deviation 1.01 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 20 degree inferior | 24.94 mm | Standard Deviation 0.97 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 30 degree inferior | 24.68 mm | Standard Deviation 0.94 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 30 degree superior | 247.77 mm | Standard Deviation 0.95 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 20 degree temporal | 24.98 mm | Standard Deviation 0.97 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 30 degree temporal | 24.29 mm | Standard Deviation 0.91 |
| Biofinity +1.50 D Add | Ocular Shape Change and Eye Growth | 20 degree nasal | 24.90 mm | Standard Deviation 1.09 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 30 degree temporal | 24.04 mm | Standard Deviation 0.81 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 20 degree inferior | 24.64 mm | Standard Deviation 0.79 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 20 degree nasal | 24.60 mm | Standard Deviation 0.93 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 20 degree superior | 24.74 mm | Standard Deviation 0.84 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 20 degree temporal | 24.71 mm | Standard Deviation 0.84 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 30 degree inferior | 24.45 mm | Standard Deviation 0.78 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 30 degree nasal | 24.51 mm | Standard Deviation 0.87 |
| Biofinity +2.50 D Add | Ocular Shape Change and Eye Growth | 30 degree superior | 24.58 mm | Standard Deviation 0.86 |
Comparison: Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.p-value: 0.05Mixed Models Analysis