Vision after Clareon Vivity versus PureSee extended‑depth‑of‑focus lens implants
Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
This study will test whether two extended‑depth‑of‑focus intraocular lenses (Clareon Vivity and PureSee) give good vision for people aged 50 and older having cataract surgery in both eyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | OMIQ Research Research network |
| Locations | 1 site (Sant Cugat del Vallès, Barcelona) |
| Trial ID | NCT07165197 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with bilateral age-related cataracts, minimal other eye disease, and biometry that allows emmetropic correction with the available IOL powers.
Not a fit: Patients with significant corneal, macular, or optic nerve disease, irregular astigmatism, prior refractive/corneal/retinal/glaucoma surgery, amblyopia, or whose IOL power needs fall outside the lens ranges are unlikely to benefit in this trial.
Why it matters
Potential benefit: If successful, these lenses could provide a broader range of clear vision and reduce reliance on glasses after cataract surgery.
How similar studies have performed: Other studies of EDOF IOLs, including published data on the Vivity lens, have shown improved intermediate vision and reduced spectacle dependence, but direct head‑to‑head comparisons between these two specific lenses are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sant Cugat del Vallès, Barcelona
- OMIQ Research — Sant Cugat del Vallès, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.