Refractive ErrorsBLINKNCT02255474
Bifocal Lenses In Nearsighted Kids
A study testing Biofinity Multifocal D +1.50 add, Biofinity Multifocal D +2.50 add and Biofinity in people with Refractive Errors, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Biofinity Multifocal D +1.50 add, Biofinity Multifocal D +2.50 add and Biofinity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2014to 24 Jun 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University College of Optometry
Columbus, Ohio, 43210
University of Houston College of Optometry
Houston, Texas, 77204
About this study
Official title: Soft Bifocal Contact Lens Myopia Control
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.
Read the 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.
- Conditions
- Refractive Errors
- Being tested
- Biofinity Multifocal D +1.50 add, Biofinity Multifocal D +2.50 add, Biofinity
- Keywords
- pediatrics, refractive error - myopia, contact lenses, intervention
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofinity Multifocal D +1.50 addDevice
This is a monthly disposable contact lens commercially available from CooperVision
Biofinity Multifocal D +2.50 addDevice
This is a monthly disposable contact lens commercially available from CooperVision
BiofinityDevice
This is a monthly disposable spherical contact lens commercially available from CooperVision
| Study group | Role | What they receive |
|---|---|---|
| Biofinity | Active comparator | Soft spherical contact lens Receives: Device: Biofinity |
| Biofinity Multifocal D +1.50 add | Experimental | The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power Receives: Device: Biofinity Multifocal D +1.50 add |
| Biofinity Multifocal D +2.50 add | Experimental | The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power Receives: Device: Biofinity Multifocal D +2.50 add |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
Secondary outcomes (3)
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).
Measured: 3 years
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).
Measured: 3 years
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start22 Sep 2014
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Jeffrey J. Walline, OD PhD, Ohio State University
- Investigators
- Jeffrey Walline, OD, PhD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255474
- Sponsor's protocol ID
- 2014H0231
- Other IDs
- U10EY023208
- Acronym
- BLINK
- Status last verified
- Feb 2021
- First submitted
- 23 Sep 2014
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chandler MA, Robich ML, Jordan LA, Mutti DO, Berntsen DA, Fenton R, Day E, Walline JJ; BLINK2 Study Group. Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial. Optom Vis Sci. 2023 Jul 1;100(7):425-431. doi: 10.1097/OPX.0000000000002040. Epub 2023 Jun 24.
PubMed 37369096Gaume Giannoni A, Robich M, Berntsen DA, Jones-Jordan LA, Mutti DO, Myers J, Shaw K, Walker MK, Walline JJ; BLINK Study Group. Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children. Optom Vis Sci. 2022 Jun 1;99(6):505-512. doi: 10.1097/OPX.0000000000001902. Epub 2022 Apr 12.
PubMed 35413027Walline JJ, Walker MK, Mutti DO, Jones-Jordan LA, Sinnott LT, Giannoni AG, Bickle KM, Schulle KL, Nixon A, Pierce GE, Berntsen DA; BLINK Study Group. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020 Aug 11;324(6):571-580. doi: 10.1001/jama.2020.10834.
PubMed 32780139Schulle KL, Berntsen DA, Sinnott LT, Bickle KM, Gostovic AT, Pierce GE, Jones-Jordan LA, Mutti DO, Walline JJ; Bifocal Lenses in Nearsighted Kids (BLINK) Study Group. Visual Acuity and Over-refraction in Myopic Children Fitted with Soft Multifocal Contact Lenses. Optom Vis Sci. 2018 Apr;95(4):292-298. doi: 10.1097/OPX.0000000000001207.
PubMed 29561497Walline JJ, Gaume Giannoni A, Sinnott LT, Chandler MA, Huang J, Mutti DO, Jones-Jordan LA, Berntsen DA; BLINK Study Group. A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods. Optom Vis Sci. 2017 Sep;94(9):856-866. doi: 10.1097/OPX.0000000000001106.
PubMed 28737608