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Accommodative Behaviors in Multifocal Contact Lenses

Accommodative Behaviors in Multifocal Contact Lenses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06064617
Enrollment
20
Registered
2023-10-03
Start date
2023-11-01
Completion date
2024-04-30
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accommodation Disorder

Brief summary

Addition lenses are often used to treat a range of eye conditions. Addition lenses are specifically used to help patients who do not have the ability to focus their eyes to see clearly up close. Eye focusing is called accommodation. Addition lenses are easy to prescribe in a pair of glasses and are often called the bifocal portion of the glasses. Addition lenses can be used for adults who have presbyopia (they cannot read up close without the aide of a bifocal) and for patients of all ages who have eye focusing problems (e.g. accommodative insufficiency, accommodative infacility, accommodative dysfunction). Addition powers can also be put into contact lenses. Contact lenses that have addition powers in them are called multifocal contact lenses. These are often marketed for patients that are 40 and over who have presbyopia, and are prescribed to help patients see up close as well as far away in their contact lenses. Multifocal contact lenses are also used in children with nearsightedness because studies have shown that some multifocal designs can slow down the progression of nearsightedness. As stated before, addition lenses can be used to treat eye focusing problems in patients of all ages, before presbyopia. What is unclear is whether the addition power in contact lenses has the same treatment effect as an addition power in a pair of glasses when they are being used to treat eye focusing problems. This study will assess how different kinds of multifocal contact lenses (center distance or center near) will change eye focusing and eye teaming in young adult patients.

Detailed description

Soft multifocal contact lenses are used for a variety of reasons in patient care. In fact, studies have shown that soft multifocal contact lenses alter accommodation. While most often used to correct presbyopic vision, these lenses are also used in the management of accommodative and binocular vision disorders along with myopia management. Multifocal contact lenses correct vision at different distances by introducing a power gradient over the eye thus providing a range of clear vision at both distance and near. For center near designs, the near addition is placed in the center of the lens, and the power becomes more negative in the periphery. 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. These lenses allow maximum near correction, even with miotic pupil size changes associated with accommodation. 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 to provide the near addition. To date, most studies have used center-distance lens designs to evaluate accommodative ability and function. Accommodative function while wearing center near lenses has likely not been studied often because these lens designs are used most in populations with no or waning accommodative ability (i.e. presbyopic patients). In this population lenses are used, specifically, to account for that accommodative inability. Center near and distance designs have varying advantages and disadvantages for presbyopic vision correction. Selection of lens design can be based on a patient's individual visual needs. There is conflicting evidence on whether the add power in soft multifocal contact lenses can be used to manage accommodative and binocular vision disorders. These lenses do offer relief of accommodative demand associated with both accommodative and binocular vision disorders. It has been hypothesized that center near multifocal contact lenses provide a greater therapeutic effect as the central portion of the lens is the addition power. There have been case reports demonstrating benefits of multifocal contact lenses in accommodative insufficiency and convergence excess. Center distance lenses are used most often for myopia management. In these situations, the interest has been to determine if the child can maintain normal accommodative function while wearing the lenses. This study will aim to determine how accommodative function varies with center distance and center near multifocal contact lenses.

Interventions

DEVICECenter-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens

Center-Near multifocal design

DEVICECenter Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens

Center-Distance multifocal design

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will not know what lens they are in

Intervention model description

This study will be an observational single-center investigation using a cross sectional design and each subject will undergo two test sessions and will wear two different contact lenses. Each test session will take approximately 2 hours. The two arms are as follow: * Center-Distance (+2.50D add) then Center-Near (+2.50D add) * Center-Near (+2.50D add) then Center-Distance (+2.50D add)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)Up to two hours (1 hour in each lens)Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.

Secondary

MeasureTime frameDescription
Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)Up to two hoursAccommodation was assessed by monocular estimation method which is done with a clinical retinoscope, in which the examiner looks at the light reflex of the retina and the patient reads small print at 40 centimeters and the examiner uses lenses to neutralize the reflex
Accommodation (in Diopters) Measured by Monocular Push-UpUp to 2 hoursAccommodation measured with a monocular push-up was measured by the examiner bringing a small target close to the eye and the patient reports when the target gets blurry. These eye focusing tests and outcomes will be compared in the lens types.
Accommodation (in Cycles Per Minute) Measured by Accommodative FacilityUp to 2 hoursAccommodation was assessed by accommodative facility which uses lenses to determine how many times a patient can clear a target in one minute by having the patient look at print 40 centimeters away and the examiner places a plus lens in front of the eye and the patient reports when the text is clear and the examiner flips the lens to a minus lens and the patient reports when the text is clear and this is done for one minute and cycles per minute are recorded
Phoria (in Prism Diopters) Measured by Modified Thorington at DistanceUp to 2 HoursVergence measures will be completed by Modified Thorington will be assessed at distance (20 feet) which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.
Phoria (in Prism Diopters) Measured by Modified Thorington at NearUp to 2 hoursVergence measures was completed with Modified Thorington will be assessed at near (40 centimeters), which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

All participants had a baseline examination where baseline clinical measures were taken. At the follow up appointment, they would wear center-distance and center-near lenses in which measurements from the baseline exam were repeated. The order of the wear lenses (center-distance and center-near) were randomized between subjects.

Participants by arm

ArmCount
Center Distance, Then Center Near
Participants had clinical measurements taken with Center Distance lenses, then Center Near Lenses
11
Center Near, Then Center Distance
Participants had clinical measurements taken with Center-Near lenses, Then Center Distance lenses
9
Total20

Baseline characteristics

CharacteristicCenter Near, Then Center DistanceTotalCenter Distance, Then Center Near
Age, Continuous23.2 years
STANDARD_DEVIATION 0.4
23.7 years
STANDARD_DEVIATION 1.2
24.1 years
STANDARD_DEVIATION 1.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants20 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants16 Participants7 Participants
Sex: Female, Male
Female
5 Participants13 Participants8 Participants
Sex: Female, Male
Male
4 Participants7 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)

Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.

Time frame: Up to two hours (1 hour in each lens)

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses.

ArmMeasureValue (MEAN)Dispersion
Center DistatnceObjective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)1.20 DioptersStandard Deviation 0.17
Center NearObjective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)1.03 DioptersStandard Deviation 0.12
Secondary

Accommodation (in Cycles Per Minute) Measured by Accommodative Facility

Accommodation was assessed by accommodative facility which uses lenses to determine how many times a patient can clear a target in one minute by having the patient look at print 40 centimeters away and the examiner places a plus lens in front of the eye and the patient reports when the text is clear and the examiner flips the lens to a minus lens and the patient reports when the text is clear and this is done for one minute and cycles per minute are recorded

Time frame: Up to 2 hours

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses

ArmMeasureValue (MEAN)Dispersion
Center DistatnceAccommodation (in Cycles Per Minute) Measured by Accommodative Facility14.05 Cycles per MinuteStandard Deviation 0.78
Center NearAccommodation (in Cycles Per Minute) Measured by Accommodative Facility12.15 Cycles per MinuteStandard Deviation 0.78
Secondary

Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)

Accommodation was assessed by monocular estimation method which is done with a clinical retinoscope, in which the examiner looks at the light reflex of the retina and the patient reads small print at 40 centimeters and the examiner uses lenses to neutralize the reflex

Time frame: Up to two hours

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses

ArmMeasureValue (MEAN)Dispersion
Center DistatnceAccommodation (in Diopters) Measured by Monocular Estimation Method (MEM)0.59 DioptersStandard Error 0.08
Center NearAccommodation (in Diopters) Measured by Monocular Estimation Method (MEM)0.18 DioptersStandard Error 0.08
Secondary

Accommodation (in Diopters) Measured by Monocular Push-Up

Accommodation measured with a monocular push-up was measured by the examiner bringing a small target close to the eye and the patient reports when the target gets blurry. These eye focusing tests and outcomes will be compared in the lens types.

Time frame: Up to 2 hours

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses

ArmMeasureValue (MEAN)Dispersion
Center DistatnceAccommodation (in Diopters) Measured by Monocular Push-Up12.26 DioptersStandard Deviation 0.45
Center NearAccommodation (in Diopters) Measured by Monocular Push-Up10.95 DioptersStandard Deviation 0.45
Secondary

Phoria (in Prism Diopters) Measured by Modified Thorington at Distance

Vergence measures will be completed by Modified Thorington will be assessed at distance (20 feet) which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.

Time frame: Up to 2 Hours

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses

ArmMeasureValue (MEAN)Dispersion
Center DistatncePhoria (in Prism Diopters) Measured by Modified Thorington at Distance0.53 Prism DioptersStandard Deviation 0.25
Center NearPhoria (in Prism Diopters) Measured by Modified Thorington at Distance0.23 Prism DioptersStandard Deviation 0.25
Secondary

Phoria (in Prism Diopters) Measured by Modified Thorington at Near

Vergence measures was completed with Modified Thorington will be assessed at near (40 centimeters), which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.

Time frame: Up to 2 hours

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses.

ArmMeasureValue (MEAN)Dispersion
Center DistatncePhoria (in Prism Diopters) Measured by Modified Thorington at Near-1.25 Prism DioptersStandard Deviation 0.88
Center NearPhoria (in Prism Diopters) Measured by Modified Thorington at Near0.05 Prism DioptersStandard Deviation 0.88

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026