Soft Bifocal Contact Lenses for Near-sightedness

(BLINK2 Trial)

No longer recruiting at 1 trial location
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how soft bifocal contact lenses might slow nearsightedness, or myopia. The main goal is to identify who benefits most from these lenses and to understand any side effects or changes upon discontinuation. Participants will wear these specialized lenses for the first two years, then switch to regular single-vision lenses in the final year. It is ideal for those already part of the BLINK Study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how these lenses can benefit others in the future.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that soft bifocal contact lenses are safe for myopia control?

Research shows that soft bifocal contact lenses are generally safe, especially for children. Studies have found that these lenses can effectively slow the progression of nearsightedness and provide comfort for users.

A detailed review of soft contact lenses highlighted some possible issues, such as eye irritation and infections, though these problems are rare. One study focusing on children with nearsightedness found the lenses both effective and safe, with no major side effects reported.

Overall, while some risks exist, evidence suggests that soft bifocal contact lenses are a safe choice for managing nearsightedness.12345

Why are researchers excited about this trial?

Most treatments for near-sightedness, like traditional single-vision contact lenses, simply correct vision by focusing light directly onto the retina. However, the soft bifocal contact lenses being studied are different because they aim to slow the progression of myopia by providing a dual-focus design. This design not only corrects distance vision but also reduces eye strain by easing focus on near objects, potentially changing how the eye grows over time. Researchers are excited about this treatment because it offers a promising way to address the root cause of myopia progression rather than just correcting its symptoms.

What evidence suggests that soft bifocal contact lenses might be an effective treatment for nearsightedness?

Studies have shown that soft bifocal contact lenses effectively control nearsightedness (myopia). Research indicates that these lenses can slow the progression of myopia and help prevent excessive eye elongation, which is linked to worsening vision. For example, the BLINK Study found that high-add power multifocal lenses slowed myopia progression by more than 30%. Other studies support these findings, showing that contact lenses with higher add power are more effective than those with lower power. Overall, the evidence strongly suggests that using soft bifocal contact lenses can help manage myopia in children.36789

Who Is on the Research Team?

JJ

Jeffrey J Walline, OD PhD

Principal Investigator

The Ohio State University College of Optometry

Are You a Good Fit for This Trial?

This trial is for individuals who were part of the BLINK Study, focusing on those with near-sightedness (myopia). It aims to identify biological factors that could predict which patients will benefit most from myopia control using soft bifocal contact lenses.

Inclusion Criteria

Participants in the BLINK Study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear soft bifocal contact lenses to assess their effect on myopia progression

2 years

Transition

Participants switch from bifocal to single vision contact lenses to assess rebound effects

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Soft Bifocal Contact Lens
Trial Overview The study tests if wearing soft bifocal contact lenses can slow down the worsening of near-sightedness. The research hinges on earlier findings; if prior results show a 30% improvement, this trial will explore additional benefits and mechanisms.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Contact lensExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

University of Houston

Collaborator

Trials
155
Recruited
48,600+

Citations

Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia ...Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation ...
Multifocal Soft Contact Lenses for the Treatment of Myopia ...Level 1 evidence supports slower myopia progression and AL elongation in children who used multifocal soft contact lenses compared with ...
1-year results of a double-blinded randomized controlled trialThe one-year results from this clinical trial show that the multifocal soft contact lenses used in the experimental group have a similar myopia control ...
No rebound with soft multifocal contact lenses for myopia ...The BLINK Study demonstrated that high-add (+2.50 D) multifocal soft contact lenses significantly slowed myopia progression. This study aimed to ...
Effect of High Add Power, Medium Add Power, or Single ...Higher add power contact lenses focus light further in front of the retina and may lead to slower myopia progression than medium add power and ...
The Safety of Soft Contact Lenses in Children - PMCThis review collates data from a range of studies to estimate the incidence of complications, specifically corneal infiltrative events and microbial keratitis,
Retardation of Myopia Progression by Multifocal Soft Contact ...Multifocal contact lenses slow progression of myopia and are one of the most effective methods to control myopia to date.
Soft contact lenses for myopia control in childrenThe research reveals myopia control soft contact lenses to be effective, safe and well tolerated in children from age 7-8. However, age alone should not be the ...
Efficacy and adverse reactions of peripheral add multifocal ...This study aims to compare the efficacy of peripheral add multifocal soft contact lenses (SCLs) (excluding bifocal SCLs) with single vision ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security