Cataract
Conditions
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 Healthcare) or the PureSee (Johnson & Johnson)
Interventions
DEVICEPhacoemulsification with implantation of an extended depth of focus intraocular lens
Comparison of two different Extended depth of focus intraocular lenses
Sponsors
OMIQ Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance-corrected binocular defocus curve at 4 m | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities | 3 months | Visual acuities in logMAR scale using ETDRS (Early Treatment Diabetic Retinopathy Study) charts |
| Distance-corrected contrast sensitivity | Three months | Contrast sensitivity using M&S device |
| Low contrast (25%) binocular distance-corrected visual acuity | 3 months | Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts |
| Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire | 3 months | Assessment of qualitative visual dysphotopsia using a specific validated questionnaire |
| Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire | 3 months | Assessment of recent use of spectacles to see at different distances using a specific questionnaire |
Countries
Spain
Outcome results
None listed