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A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods

Walline, Jeffrey J. OD, PhD, FAAO1; Gaume Giannoni, Amber OD, FAAO2; Sinnott, Loraine T. PhD1; Chandler, Moriah A. OD2; Huang, Juan OD, PhD, FAAO1; Mutti, Donald O. OD, PhD, FAAO1; Jones-Jordan, Lisa A. PhD, FAAO1; Berntsen, David A. OD, PhD, FAAO2for the BLINK Study Group

doi: 10.1097/OPX.0000000000001106
Feature Article – Public Access

SIGNIFICANCE The Bifocal Lenses In Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control.

PURPOSE The BLINK study is a National Eye Institute–sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects’ baseline characteristics and study methods.

METHODS Subjects were 7 to 11 years old, had −0.75 to −5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal “D” with a +1.50-D add power, or Biofinity Multifocal “D” with a +2.50-D add power contact lenses.

RESULTS We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ± 1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was −2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and −0.03 ± 0.08 (20/18) at near.

CONCLUSIONS The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.

1The Ohio State University College of Optometry, Columbus, Ohio

2University of Houston College of Optometry, Houston, Texas

Corresponding Author: Jeffrey J. Walline The Ohio State University College of Optometry338 W Tenth AveColumbus, OH 43210 e-mail: walline.1@osu.edu

Submitted: December 8, 2016

Accepted: May 16, 2017

Funding/Support: National Institutes of Health grants U10 EY023204, EY023206, EY023208, EY023210, and P30 EY007551; Bausch + Lomb for contact lens solutions.

Conflict of Interest Disclosure: None of the authors have reported a conflict of interest.

Author Contributions and Acknowledgments: Conceptualization: JJW, DOM, LAJ-J, DAB; Funding acquisition: JJW, DOM, LAJ-J, DAB; Investigation: JJW, AG-G, MAC, JH, DOM, DAB, BLINK Study Group; Methodology: JJW, DOM, LAJ-J, DAB; Project administration: JJW, DOM, LAJ-J, DAB; Supervision: JJW, DOM, LAJ-J, DAB; Writing – original draft: JJW, LTS, LAJ-J; Writing – review & editing: JJW, AG-G, LTS, MAC, JH, DOM, LAJ-J, DAB, BLINK Study Group; Data curation: LTS, LAJ-J; Formal analysis: LTS, LAJ-J.

BLINK (Bifocal Lenses In Nearsighted Kids) Study Group:Executive Committee: Jeffrey J. Walline (study chair), David A. Berntsen (UH Clinic principal investigator), Donald O. Mutti (OSU Clinic principal investigator), Lisa A. Jones-Jordan (Data Coordinating Center director), Donald F. Everett (NEI Program Official).

Chair’s Center: Kimberly J. Shaw (study coordinator), Juan Huang (investigator), Bradley E. Dougherty (survey consultant).

Data Coordinating Center: Loraine T. Sinnott (biostatistician), Pamela Wessel (project coordinator), Jihuyn Lee (research programmer, 2015 to present).

University of Houston Clinic Site: Laura Cardenas (clinic coordinator), Krystal L. Schulle (unmasked examiner), Dashaini V. Retnasothie (unmasked examiner, 2014–2015), Amber Gaume Giannoni (masked examiner), Anita Tic´ak Gostovic´ (masked examiner), Maria K. Walker (masked examiner), Moriah A. Chandler (unmasked examiner, 2016 to present), Mylan Nguyen (data entry, 2016 to present).

Ohio State University Clinic Site: Jill A. Myers (clinic coordinator), Alex D. Nixon (unmasked examiner), Katherine M. Bickle (unmasked examiner), Gilbert E. Pierce (unmasked examiner), Kathleen S. Reuter (masked examiner), Dustin J. Gardner (masked examiner, 2014–2016), Andrew D. Pucker (masked examiner, 2015–2016), Matthew Kowalski (masked examiner, 2016 to present).

Data Safety and Monitoring Committee: Janet T. Holbrook (chair), Jane Gwiazda (member), Timothy B. Edrington (member), John Mark Jackson (member), Charlotte E. Joslin (member).

© 2017 American Academy of Optometry