Connecting Contact Lenses and Digital Technology

State University of New York College of Optometry

Status: Completed

Conditions: Ocular Accommodation; Contact Lenses; Asthenopia; Convergence, Excess

Treatments: Device: Test Daily Disposable Soft Contact Lenses; Device: Control Daily Disposable Soft Contact Lenses

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02921087

923606

Details and patient eligibility

About

This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.

Full description

This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.

Enrollment: 23 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 to 35 years of age
2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
3. Current single-vision soft contact lens wearer
4. Monocular acuity of 20/25 or better in each eye (Snellen)
5. Self-reported minimum of 6 hours a day on digital devices
6. Self-reported complaint of eyestrain on digital devices
7. No ocular pathology and/or history of eye surgery
8. No history of strabismus or strabismus surgery
9. No gas permeable lens wear for at least 3 months
10. Subjects may not be optometrists, opticians or optometry students

Exclusion criteria

1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
2. Negative Relative Accommodation (NRA) less than +1.50 D
3. Exophoria at near > 6 prism diopters10
4. Vertical phoria > 1 prism diopter
5. Presence of tropia
6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Test followed by control

Other group

Description:

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.

Treatment:

Device: Test Daily Disposable Soft Contact Lenses

Device: Control Daily Disposable Soft Contact Lenses

Control followed by test

Other group

Description:

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.

Treatment:

Device: Test Daily Disposable Soft Contact Lenses

Device: Control Daily Disposable Soft Contact Lenses