Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control

NCT04080128 | Completed Results DMC FDA Device

• 1 other identifier: UG1EY023206
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 2

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length

  test the hypothesis that thinner subfoveal choroidal thickness (a layer of blood vessels) is associated with the outcome of greater axial elongation (eye growth) The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.

  Three years

• The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in 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 - measured by the blue decay coefficient) as measured at the Baseline BLINK 2 is associated with greater axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.

  Three years

• The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length

  test the hypothesis that exposure to light levels over 1000 lux as measured at the Baseline BLINK2 visit is associated with less axial elongation (eye growth) over three years The hypothesis relates to the two years of multifocal contact lens wear and one year of single vision contact lens wear. As such, it uses the entire sample which experiences the same contact lens wear in the BLINK2 Study.

  Three years

• Three-year Choroidal Thickness Change

  The three-year change from baseline to three years for choroidal thickness.

  3 years

• Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline

  Baseline light exposure as measured by minutes at light levels over 1000 lux. Light exposure was monitored using the Actiwatch2 (Phillips Respironics), a light-sensing and logging watch worn on the wrist. Participants wore the device for a 1 week period to monitor environmental light exposure. The illuminance was measured in lux every minute. Data were scrubbed of periods where the watch was not worn or other artifacts. Light levels over 1000 lux were added to determine time outdoors in minutes.

  Baseline

• Baseline iPRGC Activity

  Baseline iPRGC activity (cells in the back of the eye as measured by blue light-driven inputs to the pupil response - measured by the blue decay coefficient). The Blue Decay Coefficient represents the rate at which the pupil redilates in the dark after exposure to multiple 5-second pulses of red and blue light. The redilation data are fit by an exponential decay function eβt where t is time in seconds and the coefficient β is the natural log of the percent change in pupil diameter per second. Values range from -0.30 to -0.01. More positive values represent slower pupil redilation and are associated with greater, potentially beneficial ipRGC activity.

  Baseline

Secondary Outcomes (7)

• Accommodative Amplitude

  Baseline

• Lag of Accommodation

  Baseline

• Accommodative Facility

  Baseline

• Slowing of Myopia Progression - Axial Length

  Two year change (Baseline to 2-Year visit)

• Rebound of Progression - Axial Length

  One year change (2-year visit to 3-year visit)

Study Arms (1)

Contact lens

The first two years of the study all participants will wear +2.50 D multifocal contact lenses. The last year of the study, all subjects will be wearing single vision contact lenses.

Device: Contact lenses

Interventions

Contact lenses DEVICE

2.50 D multifocal contact lens years 1 and 2. Year 3 all wear a single vision contact lens.

Contact lens

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Only those participants in the original BLINK Study who have consented to continue will be enrolled in BLINK2.

You may qualify if:

• Participants in the BLINK Study

Sponsors & Collaborators

• Ohio State University: lead
• University of Houston: collaborator

Study Sites (2)

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (1)

• 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.

  PMID: 37369096 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Dr. Jeffrey Walline
• Organization: The Ohio State University

walline.1@osu.edu

614-247-6840

Study Officials

• Jeffrey J Walline, OD PhD

  The Ohio State University College of Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 6, 2019
• Study Start: September 9, 2019
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-03

Locations

US (2)