Status:

RECRUITING

Visual Performance of Clareon Vivity and PureSee IOL

Lead Sponsor:

OMIQ Research

Conditions:

Cataract

Eligibility:

All Genders

50+ years

Phase:

NA

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

June 27 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT07165197

Start Date

June 27 2025

End Date

March 1 2026

Last Update

September 10 2025

Active Locations (1)

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1

OMIQ Research

Sant Cugat del Vallès, Barcelona, Spain, 08195