Post-refractive IOL Outcomes With Clareon TruPlus
ConditionCataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaser Defined Vision
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Clareon TruPlus
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Laser Defined Vision
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov