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New treatment option for Cataract
Official title Visual Performance of Clareon Vivity and PureSee IOL
ClinicalTrials.gov ID: NCT07165197
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- History of previous refractive, cornea, retina or glaucoma surgery
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Sant Cugat del Vallès, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sant Cugat del Vallès, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.