Accommodation DisorderNCT06064617
Accommodative Behaviors in Multifocal Contact Lenses
A study testing Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens and Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens in people with Accommodation Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodation Disorder
- What is being tested?
- Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens and Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Accommodation Disorder
- Being tested
- Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens, Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact LensDevice
Center-Near multifocal design
Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact LensDevice
Center-Distance multifocal design
| Study group | Role | What they receive |
|---|---|---|
| Center Distance then Center Near Multifocal Contact Lens | Experimental | All participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained. Then participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained. Receives: Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens; Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens |
| Center Near then Center Distance Multifocal Contact Lens | Experimental | All participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained. Then all participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained. Receives: Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens; Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two hours (1 hour in each lens)
Secondary outcomes (5)
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
Measured: Up to two hours
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.
Measured: Up to 2 hours
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
Measured: Up to 2 hours
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.
Measured: Up to 2 Hours
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.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Accommodation DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Morrison, Ohio State University
- Investigators
- Ann M Morrison, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064617
- Sponsor's protocol ID
- 2023H0080
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2023
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: If there is a benefit to sharing data, then data can be shared after publication of the primary outcome paper.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accommodative Behaviors in Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT06064617
- Acronym / sponsor ID
- 2023H0080
- Conditions
- Accommodation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Center Distance then Center Near Multifocal Contact Lens | Experimental | Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens, Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact LensAll participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained. Then participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained. |
| Center Near then Center Distance Multifocal Contact Lens | Experimental | Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens, Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact LensAll participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained. Then all participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact LensCenter-Near multifocal design | Device | Center Distance then Center Near Multifocal Contact Lens, Center Near then Center Distance Multifocal Contact Lens |
| Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact LensCenter-Distance multifocal design | Device | Center Distance then Center Near Multifocal Contact Lens, Center Near then Center Distance Multifocal Contact Lens |
Primary outcome
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)
Time frame: 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.
5 secondary outcomes
Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)
Time frame: Up to two hours
Accommodation (in Diopters) Measured by Monocular Push-Up
Time frame: Up to 2 hours
Accommodation (in Cycles Per Minute) Measured by Accommodative Facility
Time frame: Up to 2 hours
Phoria (in Prism Diopters) Measured by Modified Thorington at Distance
Time frame: Up to 2 Hours
Phoria (in Prism Diopters) Measured by Modified Thorington at Near
Time frame: Up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. If there is a benefit to sharing data, then data can be shared after publication of the primary outcome paper.
Related trials for Accommodation Disorder
Not yet recruiting
Study in Young Adults to Understand How Glasses With a Small Reading Addition Affect Focusing and Eye Coordination During Vision Tasks
Healthy Young Adults, Accommodation Disorder
Recruiting
Project Independence
Accommodation, Daily Activities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Morrison, OD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens and Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens in people with Accommodation Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm) (time frame: Up to two hours (1 hour in each lens)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.