Recruiting NCT07165197
Visual Performance of Clareon Vivity and PureSee IOL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phacoemulsification with implantation of an extended depth of focus intraocular lens.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
Overview
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)
Interventions
- Device Phacoemulsification with implantation of an extended depth of focus intraocular lens
Comparison of two different Extended depth of focus intraocular lenses
Primary outcome measures
- Distance-corrected binocular defocus curve at 4 m [Time frame: 3 months]
Secondary outcome measures (5)
- Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities [Time frame: 3 months]
- Distance-corrected contrast sensitivity [Time frame: Three months]
- Low contrast (25%) binocular distance-corrected visual acuity [Time frame: 3 months]
- Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire [Time frame: 3 months]
- Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire [Time frame: 3 months]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- OMIQ Research — Sant Cugat del Vallès
Identifiers
NCT: NCT07165197 · VOR2025-HGC-01