Vision after Clareon Vivity versus PureSee extended‑depth‑of‑focus lens implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial enrolls adults aged 50 or older undergoing bilateral phacoemulsification cataract surgery and implants either the Clareon Vivity or the PureSee extended depth of focus (EDOF) intraocular lens in both eyes. Participants will be followed at scheduled visits to measure visual performance outcomes such as distance, intermediate and near visual acuity, contrast sensitivity, and patient‑reported spectacle dependence and visual disturbances. Key exclusions include prior corneal, refractive, retinal or glaucoma surgery, significant ocular surface, corneal, macular or optic nerve disease, irregular astigmatism, amblyopia, or IOL power requirements outside the available lens ranges. The trial is conducted at OMIQ Research in Sant Cugat del Vallès, Barcelona, and will cap inclusion of low astigmatism cases requiring toric-equivalent correction to a small number per group.

Why it matters

Who can join: the full rules

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).

Where it's running

• OMIQ Research
  Sant Cugat del Vallès, Barcelona, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.