Visual and Patient Reported Outcomes With Clareon TruPlus
Recruiting
Observational Study
Cataract
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
40 (estimated)
Sponsor
OVO LASIK + Lens · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 as…
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.
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