Connecting Contact Lenses and Digital Technology

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.

Official Title
-----------------
Connecting Contact Lenses and Digital Technology

Conditions
-----------------
Asthenopia, Contact Lenses, Ocular Accommodation, Convergence, Excess

Intervention / Treatment
-----------------
* Device: Test Daily Disposable Soft Contact Lenses
* Device: Control Daily Disposable Soft Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test followed by control<br>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. | Device: Test Daily Disposable Soft Contact Lenses<br>* Worn daily for 7 +/- 2 days<br>Device: Control Daily Disposable Soft Contact Lenses<br>* Worn daily for 7 +/- 2 days<br>|
| Other: Control followed by test<br>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. | Device: Test Daily Disposable Soft Contact Lenses<br>* Worn daily for 7 +/- 2 days<br>Device: Control Daily Disposable Soft Contact Lenses<br>* Worn daily for 7 +/- 2 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Symptom Improvement | 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). | Baseline and after 1 week of wearing each lens. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Preference | Based on two alternative forced choice method | 2 weeks | 
| Lag of Accommodation in Study Lenses | 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. | 1 week | 
| Convergence Insufficiency Symptom Survey (CISS) | 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. | 1 week | 
| Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | 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). | 1 week | 
| Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | Measured via Modified Thorington | 1 week |