Recruiting

Clareon PanOptix, Vivity

Sponsor:

Berkeley Eye Center

Code:

NCT06922084

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Clareon PanOptix

Clareon PanOptix PRO

Mix-and-Match PanOptix/Vivity

Study Details

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.

Conditions

Cataract

Study ID

NCT06922084

Start date

Mar 17, 2025

Status verified date

Apr, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Clareon PanOptix

Bilateral Clareon PanOptix IOL implantation

Clareon PanOptix PRO

Bilateral Clareon PanOptix PRO IOL implantation

Mix-and-Match PanOptix/Vivity

Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Primary outcome measure

  • Binocular photopic CDVA (corrected distance visual acuity) [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Tetiana Huff

713-620-7640tetiana.huff@berkeleyeye.com

Locations

Shafer Vision Institute

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Contacts

Ailinn Dunn

ailinn@shafervision.com

Principal Investigator:

Brian Shafer

Berkeley Eye Center

Recruiting

Houston, Texas, United States, 77027

Contacts

Tetiana Huff

713-620-7640tetiana.huff@berkeleyeye.com

Principal Investigator:

Morgan Micheletti, MD

More Information

Sponsor

Berkeley Eye Center

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Berkeley Eye Center on 2025-04-10.