CataractNCT07610226
Post-refractive IOL Outcomes With Clareon TruPlus
An observational study of Cataract, run by Laser Defined Vision at 1 site in United States.
Trial summary
This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2026to 23 Jun 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: 35 adults over 45 years old undergoing cataract surgery post-myopic corneal refractive surgery.
Who may be able to join
- Willing and able to understand and sign informed consent.
- Adult patients (>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
- Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
- Normal ocular findings aside from cataract.
Who cannot join
- 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, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery, except for myopic LASIK or PRK.
- Previous hyperopic refractive surgery.
- Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
- 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
Physicians Protocol
Greensboro, North Carolina, 27401
Carrie Williams, 336-288-8823, ldv2020@gmail.com
Karl Stonecipher, MD
About this study
This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ 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 BCDVA (4m)
Measured using standard ETDRS charts and recorded in logMAR
Measured: 3 months postoperatively
Secondary outcomes (5)
Binocular photopic DCIVA (66cm)
Measured using standard ETDRS charts and recorded in logMAR
Measured: 3 months postoperatively
Binocular photopic UDVA (4m), UIVA (66cm)
Measured using standard ETDRS charts and recorded in logMAR
Measured: 3 months postoperatively
Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye
Measured using standard ETDRS charts and recorded in logMAR
Measured: 3 months postoperatively
Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D)
Measured using standard ETDRS charts and recorded in logMAR
Measured: 3 months postoperatively
Refractive outcomes
sphere, cylinder, MRSE
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 posted27 May 2026
- Study start25 Jun 2026
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Jun 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser Defined Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Karl Stonecipher, MD, Principal investigator, Physicians Protocol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610226
- Sponsor's protocol ID
- KS-26-01
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 23 Jul 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-refractive IOL Outcomes With Clareon TruPlus
- ClinicalTrials.gov ID
- NCT07610226
- Acronym / sponsor ID
- KS-26-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Laser Defined VisionUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 27 May 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-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ 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
- 35 adults over 45 years old undergoing cataract surgery post-myopic corneal refractive surgery.
Key inclusion criteria (5 listed)
- Willing and able to understand and sign informed consent.
- Adult patients (>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
- Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
- Normal ocular findings aside from cataract.
Key exclusion criteria (5 listed)
- 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, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery, except for myopic LASIK or PRK.
- Previous hyperopic refractive surgery.
- Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
- Any active ocular infection or inflammation.
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 BCDVA (4m)
Time frame: 3 months postoperatively
Measured using standard ETDRS charts and recorded in logMAR
5 secondary outcomes
Binocular photopic DCIVA (66cm)
Time frame: 3 months postoperatively
Binocular photopic UDVA (4m), UIVA (66cm)
Time frame: 3 months postoperatively
Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye
Time frame: 3 months postoperatively
Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D)
Time frame: 3 months postoperatively
Refractive outcomes
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 23 Jul 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.
Karl Stonecipher, MD principal investigator
Physicians Protocol
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 Laser Defined Vision 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 5 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 23 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic BCDVA (4m) (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 23 Jul 2026.