Connecting Contact Lenses and Digital Technology
Phase: NA
Conditions: Asthenopia, Contact Lenses, Ocular Accommodation, Convergence, Excess
Sponsor: State University of New York College of Optometry

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Connecting Contact Lenses and 
Digital Technology 
 
 
 
PROTOCOL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator: Danielle Iacono, OD FAAO  
Sub-Investigators: Sharon Keh, OD FAAO; Xiaoying Zhu OD MD MS FAAO; Alexandra Benavente-Perez 
MCOptom MS PhD FAAO  
Study Coordinators: Valerie Leung, BOptom BS; Krystle Kang BS 
 
 
 
Site: SUNY College of Optometry, 33 West 42nd Street, New York, NY, 10036  
Phone: (212) 938-4052 | Fax: (212) 938-4182  

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I. 
STUDY OBJECTIVES  
This study seeks to address whether or not multifocal contact lenses may be a beneficial option for 
pre-presbyopic patients complaining of eye strain and visual discomfort while using digital devices.  
The primary outcome measure will be change in average score on a ten question Visual Comfort Survey 
using a Visual Analogue Scale (VAS) technique from baseline to day 7.  Secondary outcome measures 
include lens preference based on a two-alternative forced choice survey, symptom changes based on 
the Convergence Insufficiency Symptom Survey (CISS), symptom changes based on the Contact Lens 
Dry Eye Questionnaire-8 (CLDEQ-8), and objective measures of binocularity and accommodation. 
 
II. 
BACKGROUND AND RATIONALE  
 
American Millenials spend an average of 18 hours a day consuming media1 on smartphones, digital 
tablets and home computers – often multiple forms simultaneously. The visual demands of this type of 
work are unique and require the use of prolonged intermediate vision. For contact lens-wearing young 
adults, correcting for this working distance before the onset of presbyopia may contribute to less eye 
strain and visual discomfort.  
 
Recent studies researching contact lens discomfort have attributed symptoms to a myriad of issues 
from undiagnosed accommodative-binocular disorders, to ocular surface disease, to the angle of 
computer screens.2, 3 There is no definitive evidence stating that one variable is responsible. 
Meanwhile, the number of symptomatic patients is growing. Although “occupational” spectacles are a 
growing trend, there appears to be no contact lens recommendation for symptomatic patients. 
 
III. 
STUDY METHODOLOGY  
 
a. Study Design and Intervention 
This is a prospective, single site, randomized, double-masked, crossover pilot study. Subjects will be 
randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned 
subject numbers to either the test or control group at the first visit.  Subjects will crossover at the 
second visit.  There will be an equal number of subjects in each group.   
 
This study will evaluate the ability of multifocal contact lenses to decrease signs and symptoms of 
asthenopia for non-presbyopic patients with prolonged near and intermediate work (at least 6 hours) 
on digital devices. After informed consent, baseline testing will be performed to confirm an 
appropriate ocular health and refractive state and subjects will be screened for vergence disorders for 
which a near addition would be contraindicated. Symptoms will be measured by administering the 
CISS4 and CLDEQ-8.5 Subjects will also complete a 10-question VAS survey regarding subjective visual 
comfort at the baseline visit, at the end of day 1 and day 3 (via home diary), and at the follow-up visit 
at day 7. At the end of the study, subjects will be asked their preference in a two-alternative forced 
choice format.  
 
b.  Study Lenses 
Johnson and Johnson 1- Day Acuvue Moist Brand spherical and multifocal contact lenses will be used 
(Table 1). According to recent research,6 the preferred viewing distance on digital devices for a similar 

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age group was 63 cm which would require an add of +1.59 D. A low add yielding up to +1.25 add was 
selected to provide an intermediate near addition without compromising distance vision as much as 
would be expected with higher add powers. 
  
The site study coordinator will mask (over-label) the contact lens foils so that both examiners and 
subjects remain masked.  The lens power (distance only), will be transcribed on the new label and the 
lens lot number, and expiration date will be kept in a linking log by the unmasked coordinator The 
unmasked team member will assign a group number, “A” or “B” to match the randomization order for 
the multifocal from single vision lenses so that the examiners may dispense lenses while remaining 
masked.   
 
Table 1. Study lenses 
Brand 
Base Curve Diameter Power 
Add 
1-Day Acuvue Moist 
Multifocal 
8.4 
14.3 
Vertexed, spherical-
equivalent of manifest 
refraction 
LOW (up to +1.25) 
1-Day Acuvue Moist 
8.5 
14.0 
None 
 
 
c. Sample selection 
Up to 45 subjects may be enrolled in the study to provide at least 30 evaluable subjects (allowing for 
up to a 33% screen failure, drop-out, or poor or missing data).  A total of 30 subjects will be 
randomized to begin with either multifocal or single vision distance contact lenses. Subjects will wear 
the lenses on a daily-wear, daily-disposable schedule. Following one week (± 2 days) of lens wear, 
subjects will be evaluated and the alternate lenses dispensed.  The sample size was based on previous 
publications studying subjective and objective outcomes with multifocal and single vision contact 
lenses.7,8 Expectations for normal distributions of data and the ability to use parametric tests are 
generally met with sample sizes of about 30.  
 
d. 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  
 
Following consent, subjects will be screened further in order to exclude those with ocular surface 
disease and/or binocular disorders that would not benefit from a near addition.  
 

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e. Exclusion Criteria: 
 Corneal staining, blepharitis and/or MGD worse than Grade 2 using the Efron Grading Scale9  
 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 CLDEQ-8  
 Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)  
 
f. Study Procedures 
Potential study candidates will sign an informed consent form prior to any clinical procedures or tests 
specific to the protocol are performed.  All screening examination procedures will be performed by the 
investigator or trained personnel working under the investigator’s supervision.  Subjects will undergo 
examination to determine eligibility at the Baseline visit.  A medical, ocular and medication history will 
be obtained.  Subjects who elect to participate will complete the study as outlined in Table 2.  All tests 
and measurements will be obtained in accordance with the procedures specified in this protocol.   
 
g. Subject Discontinuation 
Subjects may discontinue participation at any time.  Investigators may withdraw a subject if their 
continued participation poses a risk to their health or vision or they do not meet the study enrollment 
criteria.  Discontinued or withdrawn subjects will have an exit assessment performed.  
 
h. Adverse Events and Safety Outcomes 
An adverse event is any new or worsened medical occurrence, disease, injury or significant clinical 
finding that occurs in subjects during the study.  These events may or may not be related to the study 
procedures or devices.  Safety outcomes, including subject symptoms and slit lamp findings, will be 
recorded. All adverse events will be recorded. Adverse events will be reported to the IRB using Good 
Clinical Practice Guidelines.   
 
The risks associated with contact lens wear are expected to be the same as for those wearing contact 
lenses in the general population.  The most common risks associated with daily disposable contact lens 
wear include: 
 Burning, stinging, tearing, redness and/or itching of the eyes 
 Contact lens related ocular discomfort 
 Foreign body sensation 
 Dryness 
 
More serious side effects are less common, and include: 
 Corneal infiltrates, ulcers or erosions 
 Corneal edema  
 Corneal neovascularization 
 Iritis 
 

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The contact lenses used as part of the study are FDA approved for daily wear in a daily disposable 
modality.  Subjects will be educated on proper use of contact lenses to minimize the risk of adverse 
events 
 
 
 

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Table 2: Study procedures 
 
Visit 1/Baseline 
(to present 
wearing no 
contact lenses) 
Visit 2  
(7 days ± 2 days from V1) 
(to present wearing Study 
Lens 1 for minimum 3 hours) 
Visit 3 
(7 days ± 2 days 
from V2) 
(to present 
wearing Study 
Lens 2 for 
minimum 3 hours) 
In study lens 
1 
In study  
lens 2 
Informed consent 
X 
 
 
 
Entering acuityA 
X 
X 
 
X 
Auto-refraction and keratometry  
X 
 
 
 
CL fit assessment 
 
X 
 
X 
Slit lamp exam with staining 
X 
 
 
 
Tear break up time 
X 
 
 
 
Manifest refractionB 
X 
 
 
 
Distance Snellen BCVA 
X 
 
 
 
Pupil size in dim and bright light 
X 
 
 
 
Unilateral cover test and stereopsis 
X 
 
 
 
Administration of CLDEQ-8, CISS, 
and Visual Comfort Survey 
X 
X 
 
X 
Ocular alignmentC 
X 
X 
 
X 
Accommodative amplitudeD 
X 
 
 
 
Accommodative responseE 
 
X 
 
X 
Negative and positive relative 
accommodation (NRA/PRA) 
X 
X 
 
X 
Monocular and binocular 
accommodative facilityF 
X 
 
 
 
Study lens order randomizationG 
X 
 
 
 
Removal of study lens and slit lamp 
exam with staining 
 
X 
 
X 
Insertion of CL and settling (15 min) 
X 
 
X 
 
CL fit assessment 
X 
 
X 
 
Distance HCHL logMAR acuity 
X 
 
X 
 
Exit Snellen acuity 
X 
 
X 
X 
BCVA = best corrected visual acuity 
HCHL = high contrast high luminance  
 
AEntering acuity to be measured in spectacles or most recent refraction in phoropter.  
BRefraction and over-refractions will be confirmed by performing red-green duochrome test. Patients will be fogged 
by +1.00D and the fog will be reduced in 0.25D steps until the patient reports equality, or until the last red response is 
reached.  
CLateral and vertical heterophoria to be measured via Modified Thorington in free space at 40cm.  
DMonocular push-up method with the Aston Accommodative Rule (20/30 letters at 40cm) with the subject reporting 
“first sustained blur” measured to the nearest one-half centimeter.  
EMeasured with WAM-5500 at 25 and 40cm.  
FPerformed using a +/-2.00 flipper in free space at 40cm working distance.  
GTo be performed by unmasked research staff  
 

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IV. 
DATA ANALYSIS 
 
a.  Data Collection 
All source data will be collected on paper source documents. Data will be entered into an Excel 
spreadsheet with double data entry to check for error before locking the data set.   
 
b. Outcome Measures  
The primary outcome is improvement of average asthenopic symptoms on digital devices as measured 
by a 10-question VAS repeated in-office after 1 week of lens wear. The VAS is widely used due to its 
simplicity and adaptability to a broad range of populations and settings.  Secondary outcomes include 
lens preference based on a two-alternative forced choice survey and changes in CISS and CLEDQ-8 and 
objective measures of accommodation and binocularity.   
 
 
c. Statistical Analysis 
The primary outcome measures will be assessed using paired t-tests. A chi-square will be used to 
assess final subject preference. Exploratory analyses may be conducted to assess trends in binocular 
findings, accommodative test results and symptoms, as well as to determine the appropriate sample 
sizes needed for future studies planned around these outcomes. 
 
 
 

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APPENDIX 
1.  VISUAL COMFORT SURVEY  
 
Subject ID: 
 
 
 
 
 
 
 
 
Date: 
 
Based on written questionnaire developed by Hayes et al. containing 10 questions regarding the level 
of ocular discomfort experienced during computer tasks11 
  
In your current contact lenses, to what extent do you experience:  
 
1. Blurred vision at near distances (e.g. book or cell phone)  
2. Blurred vision at intermediate distances (e.g. computer screen)  
3. Blurred vision at far distances (e.g. driving)  
4. Difficulty or slowness in refocusing my eyes from one distance to another  
5. Irritated or burning eyes  
6. Dry eyes  
7. Eyestrain  
8. Headache  
9. Tired eyes  
10. Sensitivity to bright lights  
  
0 (mm)  
 
 
 
 
 
 
 
 
 
 
100 (mm)  
Not at all  
 
 
 
 
 
 
 
 
 
 
Severe  
 
 
 
 
 
 
 
 
 
 

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APPENDIX 
2. Convergence Insufficiency Symptom Survey (CISS) 
Subject ID: 
 
 
 
 
 
 
 
Date: 
 
 

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APPENDIX 
3.  Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) 
Subject ID: 
 
 
 
 
 
 
 
 
Date: 
 

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REFERENCES 
1. Ember, Sydney. “Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes.” New York 
Times 28 September 2015: B1.  
2. Rueff, Erin. "Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar 
Symptoms." (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.  
3. Cooper, Jeffrey S., et al. "Care of the patient with accommodative and vergence dysfunction." 
American Optometric Association. USA (1998): 5-10.  
4. Rouse, Michael W., et al. "Validity and reliability of the revised convergence insufficiency symptom 
survey in adults." Ophthalmic and Physiological Optics 24.5 (2004): 384-390.  
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lens performance." Optometry & Vision Science 89.10 (2012): 1435-1442.  
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visual display as an indicator of near vision fatigue." Optometry & Vision Science 79.3 (2002): 158-169.  
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(2006): 266-273.  
8. Fedtke, Cathleen, et al. "Visual performance of single vision and multifocal contact lenses in non-
presbyopic myopic eyes." Contact Lens and Anterior Eye 39.1 (2016): 38-46.  
9. Efron, Nathan. "Clinical application of grading scales for contact lens complications." Optician 
213.5604 (1997): 26-34.  
10. Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-
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84.8 (2007): E738-E755