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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Clareon PanOptix

Bilateral Clareon PanOptix IOL implantation

DRUG

Clareon PanOptix PRO

Bilateral Clareon PanOptix PRO IOL implantation

DRUG

Mix-and-Match PanOptix/Vivity

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

Locations (2)

Shafer Vision Institute
Plymouth Meeting, Pennsylvania, United States
Berkeley Eye Center
Houston, Texas, United States