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Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control

NCT04080128 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 248

Last updated 2026-05-06

Study results available
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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

Interventions

DEVICE

Contact lenses

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

Sponsors & Collaborators

  • University of Houston

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Jeffrey J Walline, OD PhD · The Ohio State University College of Optometry

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2024-01-04
Completion
2024-01-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080128 on ClinicalTrials.gov