Accommodative Behaviors in Multifocal Contact Lenses
Phase: NA
Conditions: Accommodation Disorder
Sponsor: Ohio State University

Title Page 
Study Title: Accommodative Behaviors in Multifocal Contact Lenses 
NCT Number: 06064617 
Date of Document: Approved by IRB on Nov 30, 2023, Uploaded to 
Clinical Trials.gov on 08/18/2025 
 

 
Research Protocol 
Accommodative Behaviors in Multifocal Contact Lenses 
Study Objectives: 
The purpose of this study is to determine if accommodation differs with center near and 
center distance multifocal contact lenses 
Background and Rationale: 
Soft multifocal contact lenses are used for a variety of reasons in patient care. Multifocal 
contact lenses are most often used to correct presbyopic vision by providing a range of 
clear vision at both distance and near (Chu and Huang, 2010). Multifocal contact lenses 
correct vision at different distances by introducing a power gradient over the eye. They 
are designed using center near or center distance designs. For center near designs, the 
near addition is place in the center of the lens, and the power becomes more negative 
in the periphery. Conversely, for center distance designs, the distance prescription is 
placed in the center, and the power of the lens becomes more positive in the periphery 
in order to provide the near addition. Center near and distance designs have varying 
advantages and disadvantages for presbyopic vision correction, so a fitter may choose 
a specific design based on a patient’s individual visual needs. Generally, it is thought 
that center near designs provide the most accommodative relief and superior near 
vision because the near addition is centered in the pupil and able to allow maximum 
near correction, even with miotic pupil size changes associated with accommodation. 
There is growing use of soft multifocal contact lenses to slow the progression of myopia 
in juvenile populations (Walline, Walker, Mutti, et al., 2020). When used for myopia 
management, the power gradient of a soft multifocal contact lens is utilized to, 
hypothetically, alter how light focuses in the eye and influence eye growth. Specifically 
for myopia management, center distance multifocal designs are used. A center distance 
contact lens optically corrects for the distance refraction in the center of the lens 
(providing a clear distance image to the macula) while the peripheral portion, with its 
increasing plus power, generates myopic peripheral defocus. This change in peripheral 
image focus is thought to provide an optical “stop” signal for axial elongation and 
myopic progression (Berntsen and Kramer, 2013; Ticak and Walline, 2013; Walline et 
al., 2020). For myopia management, therefore, multifocal contact lenses are not being 
used to correct vision or influence accommodation. There have been conflicting reports 
as to how/if children accommodate normally while wearing multifocal contact lenses. 
(add some citations here, probably similar to below) 
Plus lenses, or add powers, in spectacles are often used in the management of 
accommodative and binocular vision disorders (Scheiman and Wick, 2008). An add 
power, or plus lens, relieves accommodative demand. There is conflicting evidence on 

whether the add power in soft multifocal contact lenses can be used to manage 
accommodative and binocular vision disorders (Gong, Troilo and Richdale, 2017; 
Jimenez, Durban and Anera, 2002; Kang, Fan, Oh, et al., 2013; Madrid-Costa, Ruiz-
Alcocer, Radhakrishnan, et al., 2011; Tarrant, Severson and Wildsoet, 2008). Some 
case reports demonstrate benefits of multifocal contact lenses in accommodative 
insufficiency and convergence excess but the evidence is not clear and many previous 
studies utilize lenses that are not readily used anymore (Rodgin, 2009; Weissman, Barr, 
Harris, et al., 2006). Studies show that soft multifocal contact lenses alter 
accommodation in participants who wear lenses, but most studies use center-distance 
lens designs, which is the most commonly used lens for myopia management (Gong et 
al., 2017; Madrid-Costa et al., 2011; Tarrant et al., 2008). 
Most studies that have evaluated accommodative ability and function while wearing soft 
multifocal contact lenses have examined center distance lenses. Because center 
distance lenses are used for myopia management, the interest has been to determine if 
children maintain normal accommodative function while wearing the lenses. 
Accommodative function while wearing center near lenses has likely not been studied 
often because these lens designs are used most in presbyopic populations who have no 
or waning accommodative ability and are using the lenses, specifically, to account for 
that accommodative inability.-Knowing how spectacle lenses with add powers 
effectively treat some binocular vision and accommodative disorders and understanding 
how center near multifocal contact lenses correct presbyopic vision, it is reasonable to 
hypothesize that center near multifocal contact lenses may provide a greater 
therapeutic effect for accommodative and binocular vision disorders than center near 
designs because the central portion of the lens is the addition power, unlike the center-
distance lens designs. This study will aim to determine how accommodative function 
varies with center distance and center near multifocal contact lenses. 
Procedures: 
Research Design 
This study will be an observational single-center investigation using a cross sectional 
design and each subject will undergo two test sessions. 
Sample 
The sample size necessary for this study is 20 subjects. The sample size calculation 
was completed using effect size with standard deviation values from previously 
published objective accommodative difference between center-distance multifocal 
contact lenses and single vision contact lenses, which found about 1.0 D ± 0.53 D 
difference (Gong et al., 2017). In order to detect a 0.5 D difference in accommodative 
amplitude between center-distance and center-near contact lenses with 90% statistical 
power, a sample of 14 participants is required. Because a study investigating this 
hypothesis has not been performed in the past, we will enroll an additional 6 patients to 
account for unknown variability in the data.  

Eligibility Criteria are: 
• Ages 18 to ≤ 30 years old 
• Acuity of 20/25 or better in both eyes with habitual contact lens prescription 
• No history of ocular disease or active ocular inflammation 
• No history of ocular or refractive surgery  
• No current history of rigid contact lens wear 
• Astigmatism ≤1.00 D 
• Free of binocular vision disorder (strabismus, amblyopia, vergence dysfunction, 
accommodative dysfunction) 
• No prior or concurrent participation in myopia control or use of low dose atropine, 
multifocal contact lenses 
• No use of any medications suspected to affect accommodation 
If a subject presents with conditions such as uncorrected refractive error or pathology, 
an appropriate referral will be made. 
Potential participants will be recruited in the following manners: 
• Word of mouth by the investigators among employees and visitors to the College 
of Optometry 
• Flyers 
• Email announcements distributed to the faculty, staff, and students at OSU 
• Electronic advertisement in the OSU Healthbeat 
• Phone calls to potentially eligible participants who are identified from a review of 
clinical records at the College of Optometry to identify those who wear soft 
contact lenses. 
Measurement 
The primary measurement of interest is accommodation, which will be quantified using 
the following techniques: 
Objective Accommodative Amplitude: This non-invasive technique quantifies the total 
focusing ability of the eye using methods that are commonly used clinically. The 
refractive power of the eye will be measured with the Grand Seiko autorefractor (a 
commercially available instrument) while study participants view a 20/30 sized letter at 
multiple stimulus positions (ranging from optical infinity to 20cm). Ten repeated 
measures will be collected at each stimulus position. For all measurements, participants 
will wear an eye patch over their left eye and view the letter target with their right eye 
while keeping their chin in a chinrest and forehead against the forehead rest. The Grand 
Seiko autorefractor uses infrared light to obtain refractive measures of the eye and the 
procedure is non-invasive. The following distances are where accommodation will be 
assessed:, 2.5 D (40 cm), and 4 D (25 cm), and 5 D (20 cm). Because multifocal 
contact lenses can interfere with the optics and readings of an autorefractor, the 
multifocal will only be worn on the left eye during this testing. The patient’s habitual 

contact lens with distance only will be on the right eye. An infrared wratten filter will be 
placed over the right eye, so that the left eye (with the multifocal) will influence 
accommodation and readings can be obtained from the right eye. 
Subjective Accommodative Amplitude: This technique quantifies the nearest position of 
clear focus using a method that is the standard technique used in a routine eye 
examination whereby the participant will be asked to view a row of 20/30 letters first 
held in close proximity to the eye (approximately 2-3 cm) and then pulled away from the 
eye along a near point rod. The participant will be instructed to report the moment when 
the letters first become blurred. The measurement will be repeated three times and 
averaged and the individual findings compared to published age norms for classification 
of reduced or adequate accommodative amplitude (Hofstetter, 1944). 
Accommodative Accuracy: This technique determines the accuracy of the eye to focus 
at a near viewing distance. A handheld light and loose trial spectacle lenses are used to 
quantify the focusing position of the eye while the participant views letters printed on a 
card. The lenses are held in front of the participant’s eye and the light shown quickly 
across the eye from arm’s length. 
Accommodative Facility: This technique determines the ability of the eye to quickly 
focus and relax, which is often needed for visual demands in a classroom. Participants 
will view a 20/30 letter at 40 cm. The examiner will then place ±2.00 D flipper lenses in 
front of the patient’s eye (plus or minus). Once the participant clears the letters, they will 
state “clear” and the examiner will flip to the other side. The number of flips per minute 
will be recorded. 
Detailed Study Procedures 
The study will enroll 20 participants from 18-30 years old. The study consists of two 
days of office visits to the OSU College of Optometry (a baseline visit, and then a 
second visit on another day with center-distance and center-near contact lenses). 
Participants will complete the study visits in the Fry Hall clinic research Lab. 
Baseline Exam: 
• Questions regarding participant demographics, medical history, ocular history, 
medication use, and refractive error (glasses and contacts) if known. 
• Visual Acuity – participants identifying letters to assess visual acuity at distance 
and near.  
• Contrast Sensitivity – participants identifying letters to identify contrast sensitivity 
at 50 cm. 
• Pupil Size – determination of pupil size using a ruler to measure diameter in 
millimeters in light and dark. 
• Ocular alignment: 
o Cover Test - participants viewing a letter or picture while an investigator 
covers the eyes with a cover paddle and assessed eye alignment. 

o Modified Thorington - Measured at distance and near. 
• Near Point of Convergence – participants viewing letters while they are moved 
closer to the eyes to assess convergence movements. 
• Stereopsis – participants wearing 3D glasses and identifying shapes in a book to 
assess depth perception. 
• Accommodation - Measures of accommodation will be performed in the following 
order using the protocols described above under “Measurements”: 
o Push-up method - Accommodative amplitudes of accommodation will be 
measured in the right eye only, 3 times. 
o Monocular estimation method (MEM) - This will be measured at 40 cm, 
in the right eye only. 
o Accommodative Facility - Accommodative facility (in cycles/minute) will 
be measured with ±2.00 D flippers in the right eye only and binocularly. 
o Grand Seiko WR-5100K – Refractive Error will be measured at several 
points:  
 0 D (distance) 
 2.5 D (40 cm) 
 4 D (25 cm) 
 5 D (20 cm) 
• Refractive Error Assessment – Non-cycloplegic central refractive error (with and 
without contact lenses). Non-cycloplegic refractive error will be assessed with the 
Grand Seiko WR-5100K. This will be done with and without Biofinity sphere 
contact lenses (that is the same prescription as the participant’s habitual contact 
lens prescription). An average of 10 readings will be calculated (both with and 
without habitual correction). 
• Dilation – participants will be dilated with 1% tropicamide. They will receive 2 
drops, 5 minutes apart.  
• Cycloplegic Central Refractive Error (without contact lenses). Cycloplegic 
refractive error will be assessed with the Grand Seiko WR-5100K. This will be 
done without contact lenses on. An average of 10 readings will be calculated. 
 
Second Visit 
• At the second visit, participants will repeat measurements completed at the first 
examination (except for dilation/cycloplegia) with a center-distance and center-
near Biofinity multifocal contact lens (both with +2.50 D add). The order will be 
randomized for each participant. The multifocals will be worn binocularly for all 
testing except for autorefraction, so that the optics of the contact lenses will not 
interfere with measurements.  
The total time for each study visit will be no more than 90 minutes. 
Study Risks 

The risks involved with the participation of this study are no greater than that incurred in 
a routine eye exam with dilation. The side effects that participants might experience are 
blurred vision (that generally affects near viewing more than distance), and light 
sensitivity. Previous studies suggest that the side effects of both concentrations are 
minimal and do not impede activities of daily living. These drops will only be instilled one 
time at one visit and side effects should wear off within 4-6 hours. All other study 
procedures are non-invasive and only involve lights as the participant places his/her 
chin on a chinrest and looks straight ahead. 
Data Collection and Participant Confidentiality 
Data will be collected on a paper study form that includes only the participant’s study 
ID. Study measures obtained with the autorefractor will be printed from the instrument 
and the participant’s study ID written on the print-out. The print-outs will then be taped 
to the paper study form and later scanned into pdf format for storage on the 
Investigator’s computer. No personally identifying information will be stored on the 
paper datasheet, or in the generation of the scanned pdf. Signed 
consent/assent/parental permission documents will be kept separate from the study 
data sheet in a binder in the Investigator’s locked laboratory, accessible only to the 
study team. The link between the study ID and the participant’s personal information will 
be maintained on the signed consent documents.   
Internal Validity 
There are no threats to internal validity. All procedures performed in the examination are 
standard procedures that have been performed frequently in other studies. While this 
project is assessing measurements in one population, there is limited threat to external 
validity because this is a project of instrument comparability and repeatability and is not 
intended to make generalizations about the population as a whole.  
Data Analysis 
Repeated measures analysis of variance (Repeated measures ANOVA) will be 
completed with measurement environment (single vision CL, center-distance CL, 
center-near CL). If differences are detected in lens type (center-distance, o center-
near), a post-hoc analysis will take place.  
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Gong, C.R., Troilo, D. & Richdale, K. (2017). Accommodation and Phoria in Children 
Wearing Multifocal Contact Lenses. Optom Vis Sci, 94, 353-360. 
Jimenez, J.R., Durban, J.J. & Anera, R.G. (2002). Maximum disparity with acuvue 
bifocal contact lenses with changes in illumination. Optom Vis Sci, 79, 170-4. 

Kang, P., Fan, Y., Oh, K., Trac, K., Zhang, F. & Swarbrick, H.A. (2013). The effect of 
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Madrid-Costa, D., Ruiz-Alcocer, J., Radhakrishnan, H., Ferrer-Blasco, T. & Montes-
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Wilkins,  
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A.G., Bickle, K.M., Schulle, K.L., Nixon, A., Pierce, G.E., et al. (2020). Effect of High 
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