Visual and Patient Reported Outcomes With Clareon TruPlus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clareon TruPlus.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Visual and Patient Reported Outcomes of Clareon TruPlus IOL in Cataract Surgery Patients
Overview
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.
Interventions
- Device Clareon TruPlus
Clareon TruPlus
Primary outcome measures
- Binocular photopic DCIVA [Time frame: 3 months postoperatively]
Secondary outcome measures (1)
- Binocular photopic CDVA [Time frame: 3 months postoperatively]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ovo Lasik + Lens — Saint Louis Park
Identifiers
NCT: NCT07648355 · MW-26-01