Visual and Patient Reported Outcomes With Clareon TruPlus

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.

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.