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

Last updated: April 3, 2025
Sponsor: Berkeley Eye Center
Overall Status: Active - Recruiting

Phase

4

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

Clareon PanOptix

Mix-and-Match PanOptix/Vivity

Clareon PanOptix PRO

Clinical Study ID

NCT06922084
95474481
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult cataract patients aged 40 years and older scheduled for age related cataractsurgery 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 theprotocol.

  • Postoperative potential visual acuity of 20/25 or better in each eye, as determinedby the investigator.

  • Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, orwith a spherical IOL and LRIs or AKs resulting in a predicted postoperativeastigmatism of less than 0.5 diopters (D).

  • Ability to understand and complete questionnaires.

Exclusion

Exclusion Criteria:

  • Women who are pregnant, planning to become pregnant during the study, orbreastfeeding.

  • Ocular conditions that could confound study results, including moderate to severecorneal pathology, irregular astigmatism, moderate to severe dry eye, preexistingretinal 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., uncontrolleddiabetes mellitus, certain autoimmune disorders).

  • Subjects with nystagmus, strabismus, zonular laxity or dehiscence, andpseudoexfoliation.

  • 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-operativeinflammation in the fellow eye)

  • Psychiatric or cognitive disorders that may impair the ability to comply with studyprocedures or provide accurate self-assessments.

  • RMS total higher-order aberrations (HOAs) >0.70 µm or coma >0.40 µm as measured bytomography or topography with a 4 mm pupil setting.

Study Design

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: Clareon PanOptix
Phase: 4
Study Start date:
March 17, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Shafer Vision Institute

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Berkeley Eye Center

    Houston, Texas 77027
    United States

    Active - Recruiting

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