Post-refractive IOL Outcomes With Clareon TruPlus
Purpose
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.
Condition
- Cataract
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. - Normal ocular findings aside from cataract.
Exclusion Criteria
- 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. - Any active ocular infection or inflammation.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Clareon TruPlus |
|
Recruiting Locations
Physicians Protocol
Greensboro, North Carolina 27401
Greensboro, North Carolina 27401
More Details
- Status
- Recruiting
- Sponsor
- Laser Defined Vision