Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

In by alicia.green

Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

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This is a non-interventional, single center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are reached. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Age ≥ 18 years
  2. History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
  3. Willing to undergo an eye exam with pupil dilation
Exclusion Criteria
  1. Moderate to severe posterior capsule opacification (2+ or more)
  2. Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
  3. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
  4. Any previous ocular surgery (excluding YAG, LASIK, PRK)
  5. Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
  6. Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
  7. Women who are pregnant at the time of screening (based on self-reported history)
  8. Medical or other problems which in the opinion of the investigator will render study participation unsafe
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