Evaluating Contact Lens Optics
Phase: NA
Conditions: Myopia
Sponsor: David A Berntsen, OD PhD

FULL PROTOCOL TITLE: Evaluating Contact Lens Optics 
 
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NCT05028790 
 
October 16, 2020 
 
 

FULL PROTOCOL TITLE: Evaluating Contact Lens Optics 
 
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PRINCIPAL INVESTIGATOR: 
David A Berntsen, OD, PhD 
Associate Professor 
University of Houston College of Optometry 
 
 
 

FULL PROTOCOL TITLE: Evaluating Contact Lens Optics 
 
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Table of Contents 
1.0 
Objectives ............................................................................................................................ 4 
2.0 
Background .......................................................................................................................... 4 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 4 
4.0 
Vulnerable Populations ........................................................................................................ 6 
5.0 
Number of Subjects.............................................................................................................. 6 
6.0 
Recruitment Methods ........................................................................................................... 6 
7.0 
Study Timelines ................................................................................................................... 6 
8.0 
Study Endpoints ................................................................................................................... 6 
9.0 
Procedures Involved ............................................................................................................. 7 
10.0 Setting .................................................................................................................................. 8 
11.0 Risks to Subjects .................................................................................................................. 9 
12.0 Potential Benefits to Subjects ............................................................................................ 10 
13.0 Withdrawal of Subjects ...................................................................................................... 10 
14.0 Costs/Payments to Subjects ............................................................................................... 10 
15.0 Confidentiality ................................................................................................................... 10 
16.0 Provisions to Protect the Privacy Interests of Subjects ...................................................... 11 
17.0 Informed Consent Process ................................................................................................. 11 
18.0 Process to Document Consent in Writing .......................................................................... 11 
19.0 HIPAA ............................................................................................................................... 11 
20.0 Data Management .............................................................................................................. 11 
21.0 Sharing of Results with Subjects ....................................................................................... 12 
22.0 Resources ........................................................................................................................... 12 
23.0 References .......................................................................................................................... 13 
 
 
 

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1.0 
Objectives 
This is a pilot study to explore the feasibility of using optical models to predict 
how multifocal contact lens designs affect retinal defocus and visual performance. 
Multifocal contact lens designs are being used and optimized for myopia control. 
However, these lens designs must be tested on-eye to measure their effect on 
retinal defocus and visual performance. This process is expensive and time 
consuming. The purpose of this study is to develop a model to predict changes in 
retinal defocus and visual performance with multifocal soft contact lenses.  
We hypothesize that optical modelling can be used to accurately predict changes 
in retinal defocus and visual performance with multifocal soft contact lenses. This 
hypothesis is based on published works that show optical models can replicate 
central and peripheral wave aberrations (Polans et al. 2015, Nadeem Akram et al. 
2018) and that some visual quality metrics can predict changes in visual 
performance due to the optical aberrations. (Ravikumar et al. 2013) 
The study will also identify visual quality metrics that are correlated with changes 
in visual performance with different multifocal contact lens designs, and how 
some optical properties of the eye change with multifocal contact lenses.  
 
2.0 
Background 
Most multifocal contact lenses being studied for myopia control such as the 
Biofinity Multifocal D,(Walline et al. 2020) Proclear Multifocal D (Walline et al. 
2013) and NaturalVue multifocal lenses (Cooper et al. 2018) were initially 
designed for presbyopia. Based on results from animal studies, (Smith 2011) it is 
hypothesized that these lenses are able to slow myopia progression by 
simultaneously providing clear foveal vision and myopic defocus. Thus, the initial 
steps in assessing the efficacy of any new myopia control lens must include an 
assessment of its effect on both visual performance and retinal defocus.  
Currently, this assessment is done on-eye in a cohort study. This process is 
expensive, time consuming and inefficient, and can severely hamper the ability to 
test several new multifocal contact lens designs.  
The rationale for this study is to create a model that can predict changes in retinal 
defocus and visual performance with novel lens designs. With this model, several 
multifocal contact lens designs can be tested, and only promising lens designs are 
manufactured for further on-eye testing. This model can then be used by us and 
other researchers to quickly test the performance of several lens designs. Lens 
designs that maintain good visual performance with a maximum myopic change 
in retinal defocus have a high potential of being a good myopia control lens that 
warrant on-eye testing in a cohort study. 
 
3.0 
Inclusion and Exclusion Criteria 
Inclusion Criteria 

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• Able to read and understand the informed consent document 
• 18 to 39 years of age (inclusive) 
• Best corrected visual acuity of 20/25 or better in the right eye 
• Refractive error from -1.00D to -6.00D with astigmatism less than or 
equal to -1.00D in the right eye (corneal plane). 
 
Exclusion Criteria 
• Any ocular or systemic conditions affecting vision, refraction, or the 
ability to wear a soft contact lens. 
• History of ocular trauma or surgery causing abnormal or distorted vision 
• Current Rigid Gas Permeable (RGP) contact lens wearers 
• Unwilling to have contact lens fit photographed 
• Pregnant and/or lactating females, by self-report 
 
A screening examination will be performed on all potential subjects to determine 
their eligibility for the study. Eligibility will be based on the listed criteria and 
will be determined by the study personnel listed on the study protocol. 
The following special populations will be excluded from the study; 
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers less than 
18 years old) 
• Pregnant women, by self report* 
• Prisoners+ 
 
* Pregnant and/or lactating women will be excluded from the study because of the 
potential for shifts in the refractive components of the eyes during pregnancy, 
which would affect the study results. In clinical practice, pregnant or lactating 
women typically do not have dilation drops instilled when not necessary, unless 
as part of a comprehensive eye examination, to avoid any potential side effects for 
the child. 
 
+ Prisoners will be excluded from the study because the study requires the 
participant to be able to come to the University of Houston College of Optometry 
due to the specialized instruments needed to complete the study visit. 
 
The following special populations may be included in the study; 
• Students for whom the Principal Investigator have direct access 
to/influence on grades 

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4.0 
Vulnerable Populations 
Study subjects may be students for whom the principal investigator has access to 
or influence over their grades. For this reason, the principal investigator will not 
be responsible for recruiting or obtaining consent from students in their own 
courses in order to prevent undue influence or coercion. A study team member 
(e.g., sub-investigator) without access to or influence on grades will be 
responsible for these tasks. 
 
 
5.0 
Number of Subjects 
The proposed study is a single site study and will be conducted at the University 
of Houston College of Optometry. To ensure that at least 10 subjects complete the 
study, up to 25 subjects will be enrolled and screened for inclusion in the study. 
For this study, a sample size of 10 gives the study 80% power at an alpha level 0f 
0.05 to detect whether a correlation of at least 0.8 exists between change in 
peripheral refraction with a multifocal contact lens compared to the change 
predicted by the model. 
This study will not present more than minimal risk to the subjects. All visits will 
involve procedures and instruments that are routinely used in optometric 
examinations. The contact lenses the subjects will wear are FDA approved. 
 
6.0 
Recruitment Methods 
Potential subjects will be recruited from the faculty, patients, students and staff 
(including relatives) of the University Eye Institute/University of Houston 
College of Optometry, as well as the surrounding community via word of mouth, 
print media (e.g., study fliers, newspaper adverts), telephone and electronic media 
(e.g., email, College of Optometry and The Ocular Surface Institute Websites, 
social media).  
 
7.0 
Study Timelines 
The study is a single visit study. Subjects will be invited to participate in a study visit that 
will last approximately 2.5 hours. We expect to take up to 9 months to complete all visits 
and an additional 3 months to complete primary analyses after the last subject completes 
the study.  
 
8.0 
Study Endpoints 

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This is a minimal risk study. Correlations between measured changes in peripheral 
refraction and visual performance will be compared to modelled changes in these 
outcomes.  
 
9.0 
Procedures Involved 
The study is a single visit, non-dispensing study of changes in visual performance and 
retinal defocus with multifocal contact lenses. The targeted number of participants is at 
least 10. Eligibility for the study will be determined during a screening examination after 
informed consent has been obtained. The study visit is expected to last approximately 2.5 
hours and only approved clinical instruments will be used for examinations. Two FDA-
approved soft contact lenses will be used in the study; a single vision contact lens and a 
multifocal contact lens. 
 
 
 
Study Procedures 
 
 
Item 
Details 
Informed Consent 
Review and complete the informed consent form 
Subject Eligibility 
Review inclusion and exclusion criteria 
Auto-refraction 
Subject’s refractive error and corneal curvature will be 
measured using a clinical, non-contact autorefractor.  
Subjective Refraction 
 
A subjective measurement of the subject's refractive 
error (i.e., prescription) will be determined using a 
phoropter. 
Slit Lamp Examination 
A slit lamp (i.e., a microscope used to examine the eye) 
will be used to assess the health of the subject's eyes. 
Standard clinical dyes (sodium fluorescein) will be used 
to assess the health of the front surface of the eye. 
Pupil dilation and cycloplegia 
After instillation of a topical anesthetic (either 0.5% 
proparacaine or 0.5% tetracaine), the pupil of each 
subject’s right eye will be pharmacologically dilated 
using either 1% tropicamide alone or in combination 
with 2.5% phenylephrine to ensure adequate pupil 
dilation. 
Optical biometry 
A non-contact optical biometer will be used to measure 
the biometrics of the eye including axial length, anterior 
chamber depth, lens thickness and vitreous chamber 
depth. 
Aberrometry 
Eye aberrations will be measured using a standard 
clinical instrument with and without wearing FDA-
approved contact lenses. 
Corneal topography 
The surface curvature and elevation of the cornea with 
and without FDA-approved contact lenses will be 
measured using a corneal topographer. 

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Contact Lens Fitting 
FDA-approved contact lenses will be fitted to the right 
eye. This includes checking the fit of the lenses 
(movement and centration), determining the appropriate 
lens power, and measuring visual acuity with the lenses. 
A picture of the contact lens fit will be taken to 
determine centration. Contact lenses will be fitted in 
random order based on a randomization schedule. Each 
subject will be fitted with a new contact lens. Contact 
lenses will not be reused between subjects. 
Visual Acuity 
High- and Low-Contrast Visual Acuity will be 
measured at various distances. Acuity measurements 
will be made with and without a standard optical 
setup to maintain a consistent artificial pupil size for 
all subjects. 
Contrast Sensitivity 
The subject’s contrast sensitivity function will be 
measured by viewing a series of targets using an 
automated contrast sensitivity measuring device. 
Testing will be done through a standard optical setup 
to maintain a consistent pupil size for all subjects. 
Intraocular Pressure 
The intraocular pressure of the eye will be measured 
using a standard clinical instrument and either 0.5% 
proparacaine or 0.5% tetracaine. 
 
Interested subjects will first go through an initial screening using a screening script 
before being scheduled. Potential subjects who pass the initial screening script will be 
scheduled and will initially complete the informed consent process. Should they agree to 
partake in the study, they will then undergo a screening examination to determine their 
eligibility for the study. As part of this examination, a standard most plus, least minus 
manifest refraction will be performed to determine refractive error and best-corrected 
visual acuity.  
 
Eligible subjects will be fitted with two different contact lenses (one sphere and one 
multifocal, in random order) in their right eye. Each subject will be fitted with a new, 
previously unworn contact lens. Next, the pupil of the right eye of the subject will be 
pharmacologically dilated. As the subjects are waiting for their pupil to be fully dilated, 
the axial length and other biometrics of the eye will be measured. After pupil dilation, the 
central and peripheral aberrations of the right eye of each subject will be measured.  
 
Lens centration, corneal topography, central and peripheral aberrations, low- and high-
contrast visual acuity, and contrast sensitivity will be measured with the first contact lens. 
After this, the second contact lens will be inserted, and the same measurements will be 
repeated. 
 
10.0 Setting 

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All study visits will be conducted at the University of Houston College of 
Optometry in the investigators’ clinical research examination lanes in the J. Davis 
Armistead Building and The Ocular Surface Institute (TOSI) in the Health 1 
Building.  
 
11.0 Risks to Subjects 
The risks to the subjects in the study are the same risks found in standard clinical 
practice. During study procedures, there is the risk of mild ocular discomfort 
during clinical procedures due to light being shined on the eye (e.g., slit lamp 
biomicroscopy), by being asked to not blink for a short period of time during a 
procedure, or through the use of topical ophthalmic diagnostic agents (e.g., 
sodium fluorescein, 1% tropicamide, 2.5% phenylephrine, topical anesthetic). 
Pupil dilation may interfere with subjects’ vision for the next few hours and make 
near work difficult and increase their sensitivity to light. Potential subjects will be 
examined to ensure that their pupil can be safely dilated. Potential discomfort 
from these procedures is transient, self-limiting and is no different than what 
occurs during pupil dilation and contact lens fitting in standard clinical practice.  
Contact lenses will be fitted on right eyes as part of this study. All contact lenses 
are FDA approved. The risks of contact lens wear are no different than if fitted in 
clinical practice. The potential for contact lens complications (listed below) are 
minimal because no contact lenses are being dispensed to the subject (all study 
contact lenses are worn during the study visit only).  
The following problems may occur with routine contact lens wear: 
• Burning, stinging, and/or itching of the eyes 
• Less comfort over time than when the lens was first placed on the eye 
• A feeling like there is something in the eye (foreign body, scratched area) 
• Reduced vision or temporary loss of vision due to peripheral infiltrates 
(white blood cells), peripheral corneal ulcers (inflammation of the cornea), 
microbial keratitis (infection of the cornea), and/or corneal erosion 
(defects in the corneal surface) 
• Local or generalized edema (swelling)  
• Corneal staining (defect in the corneal surface) 
• Redness  
• Tarsal abnormalities (bumps on the inside upper eye lid) 
• Iritis (internal inflammation of the eye) 
• Conjunctivitis (infection or inflammation of the white part of the eye or 
under the eyelids) 
• Excessive watering, unusual eye secretions, or redness of the eye 

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• Poor visual acuity 
• Blurred vision 
• Rainbows or halos around objects 
• Sensitivity to light 
• Dry eyes may also occur if lenses are worn continuously or for too long a 
time 
Subjects will be instructed that in the event they experience signs or symptoms 
associated with a potential adverse event during the study visit, they should 
immediately inform study personnel. 
 
12.0 Potential Benefits to Subjects 
There are no direct benefits that subjects are expected to gain from participating 
in this study. However, the results from this research may increase our 
understanding of how multifocal contact lens optics affects retinal defocus and 
visual performance. This information can ultimately lead to a tool to design more 
effective multifocal contact lens optics for myopia control. 
 
13.0 Withdrawal of Subjects 
Participation in the study is voluntary and subjects can withdraw from the study at 
any time. Subjects may also be withdrawn from the study by study investigators if 
they have a study-related adverse event that warrants withdrawal from the study 
or they fail to follow the study instructions. 
 
14.0 Costs/Payments to Subjects 
There is no cost to participate in the study and subjects will not be charged for any 
of the study procedures. Subjects who are eligible to participate and complete the 
study will receive a $50 Amazon gift card. Subjects must be eligible and complete 
all study procedures to receive the gift card. A parking pass will be provided for 
subjects on the day of their visit. 
 
15.0 Confidentiality 
Subjects will enter their name on the consent form, and their contact information will also 
be collected for subject scheduling purposes. Identifying information will not be collected 
on the data collection forms. A unique identification code will be assigned to each subject 
and used on the data collection forms to identify subjects. The study key linking each 
subject to their unique identification code will be stored on a password-protected file and 
will be available only to the study personnel. This key will be stored for 3 years after 
study completion. All study documents will be securely kept in the investigator’s 
laboratory. 

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16.0 Provisions to Protect the Privacy Interests of Subjects  
Study personnel will discuss the details of the study with potential subjects. This 
discussion will take place in a quiet and private area, and will take as long as 
necessary to explain all the details of the study to the understanding of the subject. 
 
17.0 Informed Consent Process 
This study will follow the University of Houston Division of Research SOP: Informed 
Consent Process for Research (HRP-090). The participant will be provided an opportunity 
to read the informed consent form and to have any questions answered before deciding 
whether to participate. Should they decide to participate, study personnel will obtain 
written informed consent from the participant. The consent form will be signed and dated 
by both the participant and a member of the study personnel who has been approved to 
obtain consent. The participant will receive a copy of the signed consent documents and 
the originals will be filed in the subject binder on site in a secure location.  
 
18.0 Process to Document Consent in Writing 
The study will follow the University of Houston Division of Research standard operating 
procedure regarding written documentation of informed consent (SOP: Written 
Documentation of Consent (HRP-091)). The consent form will be signed and dated by 
both the study subject and a member of the study personnel who has been approved to 
obtain consent. The study subject will receive a copy of the signed consent documents 
and the originals will be filed in the subject binder on site in a secure location. A copy of 
the informed consent document is included in the study related documents. 
 
19.0 HIPAA 
To assess eligibility for participation in the study, demographic information, 
general medical and eye health information will be collected on the potential 
subjects by self report.  No information will be obtained from or added to any 
medical record at the University Eye Institute. 
 
20.0 Data Management 
Data will be stored both in a paper file and electronically. Paper files will be locked in the 
research lab, and electronic data will be stored on a password protected computer. Data 
will be kept for a minimum of 3 years after completion of the project. 
 
Data analyses will be conducted using standard software packages. Descriptive statistics 
will be conducted to describe the data. Tests of normality will then be conducted 
followed by appropriate parametric or non-parametric hypothesis testing and correlation 
analyses. 
 
 

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21.0 Sharing of Results with Subjects 
At the end of the study, subjects will be informed of the order in which contact 
lenses were worn. Results from analysis of the data will not be shared directly 
with subjects but may be presented at as part of a research talk or published in an 
academic journal. 
 
22.0 Resources  
The study team has completed all necessary requirements for ethical training. 
David Berntsen OD PhD, has nearly two decades of experience conducting 
clinical care and research and will oversee all study personnel. 
 
With an abundance of contact lens wearers in the surrounding community, we do 
not anticipate difficulty identifying eligible subjects. We understand the 
possibility of slower than normal recruitment due to COVID-19; therefore, we 
have set an anticipated target of 9 months to complete all visits.  
 
All clinical equipment that will be needed to complete the study are available 
within the University of Houston College of Optometry. 
 
 

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23.0 References 
Cooper, J., B. O'Connor, R. Watanabe, R. Fuerst, S. Berger, N. Eisenberg and S. M. Dillehay 
(2018). "Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of 
Focus Multifocal Contact Lens." Eye Contact Lens 44(5): e16-e24. 
 
Nadeem Akram, M., R. C. Baraas and K. Baskaran (2018). "Improved wide-field emmetropic 
human eye model based on ocular wavefront measurements and geometry-independent gradient 
index lens." J Opt Soc Am A Opt Image Sci Vis 35(11): 1954-1967. 
 
Polans, J., B. Jaeken, R. P. McNabb, P. Artal and J. A. Izatt (2015). "Wide-field optical model of 
the human eye with asymmetrically tilted and decentered lens that reproduces measured ocular 
aberrations." Optica 2(2): 124-134. 
 
Ravikumar, A., J. D. Marsack, H. E. Bedell, Y. Shi and R. A. Applegate (2013). "Change in 
visual acuity is well correlated with change in image-quality metrics for both normal and 
keratoconic wavefront errors." J Vis 13(13): 28. 
 
Smith, E. L., 3rd (2011). "Prentice Award Lecture 2010: A case for peripheral optical treatment 
strategies for myopia." Optom Vis Sci 88(9): 1029-1044. 
 
Walline, J. J., K. L. Greiner, M. E. McVey and L. A. Jones-Jordan (2013). "Multifocal contact 
lens myopia control." Optom Vis Sci 90(11): 1207-1214. 
 
Walline, J. J., M. K. Walker, D. O. Mutti, L. A. Jones-Jordan, L. T. Sinnott, A. G. Giannoni, K. 
M. Bickle, K. L. Schulle, A. Nixon, G. E. Pierce, D. A. Berntsen and for the BLINK Study 
Group (2020). "Effect of High Add Power, Medium Add Power, or Single-Vision Contact 
Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial." JAMA 
324(6): 571-580.