CataractNCT07648355
Visual and Patient Reported Outcomes With Clareon TruPlus
An observational study of Cataract, run by OVO LASIK + Lens at 1 site in United States.
Trial summary
This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon TruPlus
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 11 Jul 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.
Who may be able to join
- Willing and able to understand and sign informed consent.
- Adult patients (>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL.
- Normal ocular findings aside from cataract and mild dry eye.
Who cannot join
- Subjects targeted for monovision.
- Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, amblyopia, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including LASIK (excluding minor lid procedures).
- Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities.
- Participation in another clinical study that could interfere with the results.
- Any active ocular infection or inflammation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ovo Lasik + Lens
Saint Louis Park, Minnesota, 55416
Ashley Prepeluh, 952-204-5060, ashley.prepeluh@ovoeye.com
Martha F Whiting, MD
About this study
Official title: Visual and Patient Reported Outcomes of Clareon TruPlus IOL in Cataract Surgery Patients
This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire.
- Conditions
- Cataract
- Being tested
- Clareon TruPlus
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon TruPlusDevice
Clareon TruPlus
| Study group | Role | What they receive |
|---|---|---|
| Clareon TruPlus | Not described Receives: Device: Clareon TruPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic DCIVA
Measured using a standardized ETDRS chart at 66cm.
Measured: 3 months postoperatively
Secondary outcomes (1)
Binocular photopic CDVA
Measured using a standardized ETDRS chart at 4m.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start2 Jun 2026
- Primary completion11 Jul 2027 (estimated)
- Study completion11 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OVO LASIK + Lens
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Martha Whiting, MD, Principal investigator, OVO Lasik and Lens LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648355
- Sponsor's protocol ID
- MW-26-01
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Patient Reported Outcomes of Clareon TruPlus IOL in Cataract Surgery Patients
- ClinicalTrials.gov ID
- NCT07648355
- Acronym / sponsor ID
- MW-26-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OVO LASIK + LensUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 11 Jul 2027 (estimated)
- Study completion
- 11 Jul 2027 (estimated)
- First posted
- 15 Jun 2026 (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.
This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon TruPlus | – | Device: Clareon TruPlus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.
Key inclusion criteria (3 listed)
- Willing and able to understand and sign informed consent.
- Adult patients (>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL.
- Normal ocular findings aside from cataract and mild dry eye.
Key exclusion criteria (6 listed)
- Subjects targeted for monovision.
- Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, amblyopia, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including LASIK (excluding minor lid procedures).
- Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities.
- Participation in another clinical study that could interfere with the results.
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 |
|---|---|---|
| Clareon TruPlusClareon TruPlus | Device | Clareon TruPlus |
Primary outcome
Binocular photopic DCIVA
Time frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 66cm.
1 secondary outcome
Binocular photopic CDVA
Time frame: 3 months postoperatively
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 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Martha Whiting, MD principal investigator
OVO Lasik and Lens LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by OVO LASIK + Lens 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jun 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?
Contact Ashley Prepeluh (952-204-5060, ashley.prepeluh@ovoeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic DCIVA (time frame: 3 months postoperatively). 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 15 Jun 2026.