Presbyopia CorrectionNCT07218731
Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses
A study testing Multifocal contact lenses and Spherical contact lenses in people with Presbyopia Correction and Presbyopia, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia Correction, Presbyopia
- What is being tested?
- Multifocal contact lenses and Spherical contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 40 years of age.
- Ability to give informed consent.
- Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
- Require an add power of +0.75 D or greater when tested at 40cm.
- Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
Who cannot join
- Current or active inflammation or infection as determined by the Investigator.
- Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
- History of refractive surgery.
- Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
- Is pregnant or lactating or planning a pregnancy during enrollment of the study.
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
- Have been diagnosed with dry eye previously
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Official title: Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasse
The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.
- Conditions
- Presbyopia Correction, Presbyopia
- Being tested
- Multifocal contact lenses, Spherical contact lenses
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal contact lensesDevice
Multifocal contact lenses
Spherical contact lensesDevice
spherical contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Multifocal contact lenses | Active comparator | multifocal contact lenses Receives: Device: Multifocal contact lenses |
| Spherical contact lenses with reading glasses | Active comparator | spherical contact lenses used with reading glasses Receives: Device: Spherical contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference Survey
Percentage of participants who prefer the multifocal lenses compared to spherical lenses with reading glasses.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start8 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presbyopia CorrectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Fogt, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218731
- Sponsor's protocol ID
- STUDY20252007
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasse
- ClinicalTrials.gov ID
- NCT07218731
- Acronym / sponsor ID
- STUDY20252007
- Conditions
- Presbyopia Correction, Presbyopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal contact lenses | Active comparator | Device: Multifocal contact lensesmultifocal contact lenses |
| Spherical contact lenses with reading glasses | Active comparator | Device: Spherical contact lensesspherical contact lenses used with reading glasses |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 40 years of age.
- Ability to give informed consent.
- Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
- Require an add power of +0.75 D or greater when tested at 40cm.
- Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
Key exclusion criteria (8 listed)
- Current or active inflammation or infection as determined by the Investigator.
- Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
- History of refractive surgery.
- Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
- Is pregnant or lactating or planning a pregnancy during enrollment of the study.
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 |
|---|---|---|
| Multifocal contact lensesMultifocal contact lenses | Device | Multifocal contact lenses |
| Spherical contact lensesspherical contact lenses | Device | Spherical contact lenses with reading glasses |
Primary outcome
Preference Survey
Time frame: 8 weeks
Percentage of participants who prefer the multifocal lenses compared to spherical lenses with reading glasses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. The data will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifocal contact lenses and Spherical contact lenses in people with Presbyopia Correction and Presbyopia, 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Preference Survey (time frame: 8 weeks). 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 24 Sep 2026.