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NCT Number: NCT07165197

Visual Performance of Clareon Vivity and PureSee IOL

This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee (Johnson & Johnson)

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OMIQ Research

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location status: Recruiting

Location contact

Anna Romero, Administration

CONTACT

[email protected]

+34937071936

Mercè Guarro, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of any sex and race aged 50 years or older
  • Patients undergoing bilateral age-related cataract surgery with a lens opacity grade 3 or higher in the LOCS III grading scale
  • Willing to receive implantation of an EDOF IOL
  • Willing to sign the informed consent and attend the study visits

Exclusion criteria

  • Requirement of a spherical or toric power of the IOL to achieve emmetropia beyond the available range of either of the two lenses
  • The number of patients included with low astigmatism that require an equivalent to a T2 toric IOL will be capped to 10 patients/group
  • Irregular astigmatism
  • Contact lens wear in the previous 3 weeks before biometry
  • Moderate or severe ocular surface, corneal, macular or optic nerve disease that in opinion of the investigator precludes the desired functional results
  • History of previous refractive, cornea, retina or glaucoma surgery
  • Eyes with a clear lens demanding a refractive lens exchange
  • Amblyopia in any eye
  • Significant previous ocular trauma
  • Pregnancy
  • A systemic condition that, in the opinion of the investigator, precludes the reliable assessments required in the study (i.e., dementia) or participation in the study (i.e., severe mobility problems).

Treatment and study plan

Phacoemulsification with implantation of an extended depth of focus intraocular lens

Device

Comparison of two different Extended depth of focus intraocular lenses

Primary outcomes

  1. Distance-corrected binocular defocus curve at 4 m

    Time frame: 3 months

Secondary outcomes

  1. Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities

    Time frame: 3 months

    Visual acuities in logMAR scale using ETDRS (Early Treatment Diabetic Retinopathy Study) charts

  2. Distance-corrected contrast sensitivity

    Time frame: Three months

    Contrast sensitivity using M&S device

  3. Low contrast (25%) binocular distance-corrected visual acuity

    Time frame: 3 months

    Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts

  4. Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire

    Time frame: 3 months

    Assessment of qualitative visual dysphotopsia using a specific validated questionnaire

  5. Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire

    Time frame: 3 months

    Assessment of recent use of spectacles to see at different distances using a specific questionnaire

Sponsors and collaborators

Lead sponsor

OMIQ Research

Network

Registry information

Official study title

Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery

Acronym: PURVI2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 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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