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NCT Number: NCT06924944

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

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

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Key information

Conditions

Correction Vision Surgery Cataract Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

Utah Eye Centers

Ogden, Utah, 84403, United States

Location status: Recruiting

Location contact

Rachel Buchanan

CONTACT

[email protected]

8014099873

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL

Primary outcomes

  1. Binocular photopic uncorrected distance VA (at 3 months)

    Time frame: at 3 months

Secondary outcomes

  1. • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)

    Time frame: at 3 months

Other outcomes

  1. Monocular uncorrected distance, intermediate, and near VA

    Time frame: at 3 months

  2. Monocular and binocular best distance corrected distance, intermediate, and near VA

    Time frame: at 3 months

  3. Binocular photopic low contrast distance corrected VA

    Time frame: at 3 months

  4. Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye

    Time frame: at 3 months

  5. Mean difference of MRSE between dominant and non-dominant eye

    Time frame: at 3 months

  6. % of eyes with absolute prediction error less than or equal to 0.5D

    Time frame: at 3 months

  7. Visual disturbances via QUVID questionnaire

    Time frame: at 3 months

  8. Potential association between HOA (SA and coma) and monocular DCVAs

    Time frame: at 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Buchanan

CONTACT

[email protected]

8014099873

Sponsors and collaborators

Lead sponsor

Utah Eye Centers

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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