Bifocal Lenses In Nearsighted Kids (BLINK)

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Biofinity; Device: Biofinity Multifocal D +1.50 add; Device: Biofinity Multifocal D +2.50 add

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.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University College of Optometry
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biofinity; Soft spherical contact lens	Device: Biofinity; This is a monthly disposable spherical contact lens commercially available from CooperVision
Experimental: Biofinity Multifocal D +1.50 add; The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power	Device: Biofinity Multifocal D +1.50 add; This is a monthly disposable contact lens commercially available from CooperVision
Experimental: Biofinity Multifocal D +2.50 add; The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power	Device: Biofinity Multifocal D +2.50 add; This is a monthly disposable contact lens commercially available from CooperVision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	3 years

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Eye Institute (NEI); University of Houston
• Investigators: Study Chair: Jeffrey Walline, OD, PhD, Ohio State University

Publications and helpful links

General Publications

• Gaume 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.
• Walline 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.
• Schulle 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.
• Walline 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2014
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; intervention; contact lenses; refractive error - myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 2014H0231; U10EY023208 (U.S. NIH Grant/Contract)