Cataract
Conditions
Brief summary
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Interventions
DEVICEClareon PanOptix
Bilateral Clareon PanOptix IOL implantation
DRUGClareon PanOptix PRO
Bilateral Clareon PanOptix PRO IOL implantation
DRUGMix-and-Match PanOptix/Vivity
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Sponsors
Sengi
Berkeley Eye Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes. * Ability to understand and sign an ethics committee-approved informed consent form. * Willingness and ability to attend all scheduled study visits as required by the protocol. * Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator. * Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D). * Ability to understand and complete questionnaires.
Exclusion criteria
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding. * Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy. * Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma). * Participation in another clinical study that could interfere with the results. * Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders). * Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation. * Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye). * Participants desiring monovision. * Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye) * Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments. * RMS total higher-order aberrations (HOAs) \>0.70 µm or coma \>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular photopic CDVA (corrected distance visual acuity) | 3 months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA) | 3 months postoperatively | — |
| Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line) | 3 months postoperatively | — |
| Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA). | 3 months postoperatively | — |
| Binocular photopic distance corrected defocus curve | 3 months postoperatively | Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision. |
| Monocular photopic distance corrected defocus curves | 3 months postoperatively | Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision. |
| Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity) | 3 months postoperatively | — |
| Refractive outcomes | 3 months postoperatively | Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism. |
| Pupil size | 3 months postoperatively | Under both photopic and mesopic conditions. |
| Patient-reported outcomes using a questionnaire about visual disturbances (QUVID) | 3 months postoperatively | — |
| Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT) | 3 months postoperatively | — |
| Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd) | 3 months postoperatively | — |
Countries
United States
Contacts
Primary ContactTetiana Huff
Outcome results
None listed