Visual and Patient Reported Outcomes With Clareon TruPlus
ConditionCataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOVO LASIK + Lens
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Clareon TruPlus
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
OVO LASIK + Lens
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov