Health TrialsbyHealthPanel

Visual Performance of Clareon Vivity and PureSee IOL

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorOMIQ Research

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phacoemulsification with implantation of an extended depth of focus intraocular lens

    Device

    Comparison of two different Extended depth of focus intraocular lenses

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Extended depth of focus intraocular lens Clareon VivityExperimental treatment 1 intervention
Group B: Extended depth of focus intraocular lens PureSeeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Distance-corrected binocular defocus curve at 4 m

Time frame
3 months

Secondary outcomes

1

Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities

Visual acuities in logMAR scale using ETDRS (Early Treatment Diabetic Retinopathy Study) charts

Time frame
3 months
2

Distance-corrected contrast sensitivity

Contrast sensitivity using M\&S device

Time frame
Three months
3

Low contrast (25%) binocular distance-corrected visual acuity

Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts

Time frame
3 months
4

Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire

Assessment of qualitative visual dysphotopsia using a specific validated questionnaire

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OMIQ Research

Lead sponsor

Source ClinicalTrials.gov
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