Connecting Contact Lenses and Digital Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Subjective Symptom Improvement
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 to 35 years of age
- •Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
- •Current single-vision soft contact lens wearer
- •Monocular acuity of 20/25 or better in each eye (Snellen)
- •Self-reported minimum of 6 hours a day on digital devices
- •Self-reported complaint of eyestrain on digital devices
- •No ocular pathology and/or history of eye surgery
- •No history of strabismus or strabismus surgery
- •No gas permeable lens wear for at least 3 months
- •Subjects may not be optometrists, opticians or optometry students
Exclusion Criteria
- •Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
- •Negative Relative Accommodation (NRA) less than +1.50 D
- •Exophoria at near > 6 prism diopters10
- •Vertical phoria > 1 prism diopter
- •Presence of tropia
- •Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
- •Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)
Outcomes
Primary Outcomes
Subjective Symptom Improvement
Time Frame: Baseline and after 1 week of wearing each lens.
The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).
Secondary Outcomes
- Convergence Insufficiency Symptom Survey (CISS)(1 week)
- Lens Preference(2 weeks)
- Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)(1 week)
- Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens(1 week)
- Lag of Accommodation in Study Lenses(1 week)
Investigators
Danielle Iacono
Assistant Clinical Professor
State University of New York College of Optometry