Multifocal Contact Lenses for Presbyopia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Systemic medications

Disqualifiers: Eye disease, Refractive surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the experience of wearing multifocal contact lenses with using regular contact lenses and reading glasses. It focuses on assisting those with presbyopia, a common condition that makes close-up vision difficult with age. Individuals over 40 who need reading glasses for clear close-up vision may qualify for this study. The trial will evaluate the effectiveness and comfort of each option in everyday use. As an unphased study, it offers a unique opportunity to explore new ways to enhance vision and comfort.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using any medications that might affect the study results, you may not be eligible to participate.

What prior data suggests that these contact lenses are safe for presbyopia?

Research has shown that multifocal contact lenses are generally safe to use. Studies have found that they improve close-up vision while maintaining clear distance vision, without affecting contrast sensitivity. The FDA has approved these lenses for treating presbyopia, a condition involving difficulty focusing on nearby objects, and they are widely used.

Patient satisfaction scores exceed 90 out of 100 for both distance and middle-range vision, indicating that most users are pleased with the performance of multifocal lenses.

No major safety issues have been reported, making these lenses a well-tolerated choice for people with presbyopia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about multifocal contact lenses for presbyopia because they offer a convenient, all-in-one solution for both distance and near vision. Unlike traditional spherical contact lenses that require additional reading glasses for close-up tasks, multifocal lenses integrate multiple prescriptions into one lens. This design mimics the eye's natural way of focusing, potentially providing a seamless transition between distances. By eliminating the need for reading glasses, multifocal lenses could enhance daily convenience and comfort for those with presbyopia.

What evidence suggests that this trial's treatments could be effective for presbyopia?

Research has shown that multifocal contact lenses, one of the treatments studied in this trial, can effectively improve vision for people with presbyopia, a condition that makes it difficult to see things up close. One study found that these lenses provide clear vision both near and far without affecting contrast sensitivity. Users report high satisfaction, with scores of about 96.2 out of 100 for distance vision and 85.0 out of 100 for near vision. Another study found that these lenses enhance vision at various distances while maintaining good overall visual quality. This trial compares multifocal contact lenses to spherical contact lenses used with reading glasses, offering a promising option for managing presbyopia without reading glasses. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people at least 40 years old with presbyopia, who can see clearly at a distance with correction (20/25 vision), need extra magnification (+0.75D) for close work, and are in stable health without medication changes in the past month. It's not for those with eye diseases/infections, dry eye history, allergies to lens solutions or fluorescein, recent eye surgery, pregnancy/lactation plans during the study period.

Inclusion Criteria

Ability to give informed consent

Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit

Require an add power of +0.75 D or greater when tested at 40cm

Exclusion Criteria

Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

I do not have any ongoing infections or inflammation.

I do not have any current eye diseases or infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear either multifocal contact lenses or spherical contact lenses with reading glasses to assess wear experience

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multifocal contact lenses
• Spherical contact lenses

Trial Overview The study compares user experience between wearing multifocal contact lenses versus spherical contact lenses paired with reading glasses. Participants will try both options to determine which provides better ease of use and visual satisfaction when correcting presbyopia.

How Is the Trial Designed?

Group I: Spherical contact lenses with reading glasses Active Control 1 Intervention

spherical contact lenses used with reading glasses

Group II: Multifocal contact lenses Active Control 1 Intervention

multifocal contact lenses

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37164776/

Presbyopia correction with multifocal contact lenses Conclusion: Average silent reading speed in a presbyopic population was found improved with MF compared to SV CL correction and was faster with ...

2. nature.com nature.com/articles/s41598-024-55918-5

Efficacy of a new refractive multifocal contact lens for ... Refractive multifocal contact lenses improved near vision while maintaining distance vision in presbyopic patients, without compromising contrast sensitivity.

3. seattleeyecaredoctor.com seattleeyecaredoctor.com/multifocal-contact-lenses-complete-presbyopia-guide-2025/

Multifocal Contact Lenses: Complete Presbyopia Guide 2025 Patient satisfaction scores were impressive: 96.2/100 for distance, 91.9/100 for intermediate, and 85.0/100 for near vision. Market Growth: The global contact ...

4. mdpi.com mdpi.com/2075-1729/15/5/700

Pilot Study Evaluating the Early Clinical Outcomes ... The CSCL Presbycustom effectively restores visual acuity across distances in presbyopic patients while maintaining functional visual quality and stereopsis.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1367048423003466

Multifocal contact lens success predictability Overall vision satisfaction (OVS) was good at both dispensing and 1-week follow-up (84.0 ± 15.3 points and 81.2 ± 17.1 respectively, Table 2). OVS scores at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12582616/

Six-month performance and safety of an iris-fixated ... Implantation of foldable iris-fixated pIOLs has been proven safe and effective for myopia correction, with or without myopic astigmatism.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220007B.pdf

Summary of Safety and Effectiveness Data (SSED) Precision7™ Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S136704842400050X

BCLA CLEAR Presbyopia: Management with contact ... This paper seeks to outline the history, market situation, clinical management and product performance related to the correction of presbyopia with both ...