Accommodative Relief for Uncomfortable Non-Presbyopes

Ohio State University84 enrolled

Overview

This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Asthenopia

Interventions

Multifocal Contact LensDEVICE

The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks

Single Vision Contact LensDEVICE

The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Visual acuity of 20/25 or better in both eyes with habitual contact lenses * -0.75 D or more myopic in both eyes * -0.75 D or less astigmatism in both eyes * Current single vision contact lens wearer who does not require a reading aid * CLDEQ-8 score of 12 or more points with habitual contact lenses * No history of ocular surgery or medication * Reports digital device use of at least 3 hours per day * No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes) * No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

Locations (1)

The Ohio State University College of Optometry

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score

After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms

Time frame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)

Data from ClinicalTrials.gov

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