RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-17

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06922084

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Tetiana Huff

CONTACT

713-620-7640

tetiana.huff@berkeleyeye.com

Principal Investigator

Morgan Micheletti, MD

PRINCIPAL_INVESTIGATOR

Berkeley Eye Center

Study Locations (Sites)

Shafer Vision Institute

Plymouth Meeting, Pennsylvania, 19462

United States

Berkeley Eye Center

Houston, Texas, 77027

United States

Collaborators and Investigators

Sponsor: Berkeley Eye Center

Morgan Micheletti, MD, PRINCIPAL_INVESTIGATOR, Berkeley Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-03-17

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Cataract