A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Purpose
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.
Condition
- Cataract
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Bilateral Clareon PanOptix IOL implantation |
|
|
|
Experimental Bilateral Clareon PanOptix Pro IOL implantation |
|
|
|
Experimental Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye |
|
Recruiting Locations
Shafer Vision Institute
Plymouth Meeting, Pennsylvania 19462
Plymouth Meeting, Pennsylvania 19462
Berkeley Eye Center
Houston, Texas 77027
Houston, Texas 77027
More Details
- NCT ID
- NCT06922084
- Status
- Recruiting
- Sponsor
- Berkeley Eye Center