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NCT07898917
PureSee/Odyssey Mix-and-Match IOL
Conditions: Cataract
Sex: All
Ages: 35 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: Gainesville Eye Associates
Location: North Georgia Eye Associates Gainesville Georgia
Summary
Observational, prospective, bilateral, single-arm investigator-initiated study. Single cohort at one site: TECNIS PureSee intraocular lens in the dominant eye and TECNIS Odyssey intraocular lens in the non-dominant eye. There is no control arm, and the study is not masked.
Eligibility Criteria
Inclusion Criteria:
• Adult (age 35 or older) patients undergoing age-related cataract surgery.
Exclusion Criteria:
* Moderate-to-severe disease state, as deemed by the surgeon, that could increase the risk of complicated cataract surgery, including pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery.
* The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
* Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Source: ClinicalTrials.gov (NCT07898917). StuddyBuddy aggregates publicly available trial information.