Cataract
Conditions
Brief summary
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.
Interventions
DEVICEClareon TruPlus
Clareon TruPlus
Sponsors
Laser Defined Vision
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular photopic BCDVA (4m) | 3 months postoperatively | Measured using standard ETDRS charts and recorded in logMAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular photopic DCIVA (66cm) | 3 months postoperatively | Measured using standard ETDRS charts and recorded in logMAR |
| Binocular photopic UDVA (4m), UIVA (66cm) | 3 months postoperatively | Measured using standard ETDRS charts and recorded in logMAR |
| Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye | 3 months postoperatively | Measured using standard ETDRS charts and recorded in logMAR |
| Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D) | 3 months postoperatively | Measured using standard ETDRS charts and recorded in logMAR |
| Refractive outcomes | 3 months postoperatively | sphere, cylinder, MRSE |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKarl Stonecipher, MD
Physicians Protocol
Outcome results
None listed