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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cataract
Intervention / Treatment

-

Contacts and Locations

Plymouth Meeting

Shafer Vision Institute, Plymouth Meeting, Pennsylvania, United States, 19462

Houston

Berkeley Eye Center, Houston, Texas, United States, 77027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Berkeley Eye Center,

Morgan Micheletti, MD, PRINCIPAL_INVESTIGATOR, Berkeley Eye Center

Study Record Dates

2026-04