Phase
Condition
Vision Loss
Eye Disease
Eye Disorders/infections
Treatment
Clareon PanOptix
Mix-and-Match PanOptix/Vivity
Clareon PanOptix PRO
Clinical Study ID
Ages > 40 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Shafer Vision Institute
Plymouth Meeting, Pennsylvania 19462
United StatesActive - Recruiting
Berkeley Eye Center
Houston, Texas 77027
United StatesActive - Recruiting
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