Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses

The Ohio State University

Status: Enrolling

Conditions: Presbyopia Correction; Presbyopia

Treatments: Device: Multifocal contact lenses; Device: Spherical contact lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07218731

STUDY20252007

Details and patient eligibility

About

The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 40 years of age.
2. Ability to give informed consent.
3. Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
4. Require an add power of +0.75 D or greater when tested at 40cm.
5. Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.

Exclusion criteria

1. Current or active inflammation or infection as determined by the Investigator.
2. Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
3. History of refractive surgery.
4. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
5. Is pregnant or lactating or planning a pregnancy during enrollment of the study.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
7. Have been diagnosed with dry eye previously
8. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Multifocal contact lenses

Active Comparator group

Description:

multifocal contact lenses

Treatment:

Device: Multifocal contact lenses

Spherical contact lenses with reading glasses

Active Comparator group

Description:

spherical contact lenses used with reading glasses

Treatment:

Device: Spherical contact lenses