Connecting Contact Lenses and Digital Technology

Not Applicable

Completed

Conditions: Ocular Accommodation
Asthenopia
Contact Lenses
Convergence, Excess

Interventions: Device: Test Daily Disposable Soft Contact Lenses
Device: Control Daily Disposable Soft Contact Lenses

Registration Number: NCT02921087

Lead Sponsor: State University of New York College of Optometry

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test followed by control	Test Daily Disposable Soft Contact Lenses	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.
Test followed by control	Control Daily Disposable Soft Contact Lenses	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.
Control followed by test	Test Daily Disposable Soft Contact Lenses	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.
Control followed by test	Control Daily Disposable Soft Contact Lenses	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.

Primary Outcome Measures

Name	Time	Method
Subjective Symptom Improvement	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 Outcome Measures

Name	Time	Method
Convergence Insufficiency Symptom Survey (CISS)	1 week	Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.
Lens Preference	2 weeks	Based on two alternative forced choice method
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)	1 week	CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens	1 week	Measured via Modified Thorington
Lag of Accommodation in Study Lenses	1 week	Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.