RECRUITINGINTERVENTIONAL
Visual Performance of Clareon Vivity and PureSee IOL
Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form and attend the study visits
Who Should NOT Join This Trial:
- 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).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
DEVICE
Phacoemulsification with implantation of an extended depth of focus intraocular lens
Comparison of two different Extended depth of focus intraocular lenses
Locations (1)
OMIQ Research
Sant Cugat del Vallès, Barcelona, Spain