Clinical trial NCT06924944: Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
Official title: Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Correction Vision Surgery
Cataract Surgery
Lead sponsor: Utah Eye Centers
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with bilateral age-related cataract patients with history of myopic refractive surgery (LASIK/PRK)

Brief summary: Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses


Eligibility criteria: Inclusion Criteria:

* o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs

  * Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment
  * Potential acuity measured post-operatively 20/25 or better in both eyes
  * Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision

Exclusion Criteria:

* o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc.

  * Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK
  * Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities
  * Total HOA cutoff of ≤0.5, coma ≤0.3
  * RLE patients

Primary outcomes:
measure: Binocular photopic uncorrected distance VA (at 3 months)
timeFrame: at 3 months
Secondary outcomes:
measure: • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)
timeFrame: at 3 months
Other outcomes:
measure: Monocular uncorrected distance, intermediate, and near VA
timeFrame: at 3 months
measure: Monocular and binocular best distance corrected distance, intermediate, and near VA
timeFrame: at 3 months
measure: Binocular photopic low contrast distance corrected VA
timeFrame: at 3 months
measure: Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye
timeFrame: at 3 months
measure: Mean difference of MRSE between dominant and non-dominant eye
timeFrame: at 3 months
measure: % of eyes with absolute prediction error less than or equal to 0.5D
timeFrame: at 3 months
measure: Visual disturbances via QUVID questionnaire
timeFrame: at 3 months
measure: Potential association between HOA (SA and coma) and monocular DCVAs
timeFrame: at 3 months
Locations:
city: Ogden
country: United States
facility: Utah Eye Centers
state: Utah
Study officials:
References: