CataractPURVI2NCT07165197
Visual Performance of Clareon Vivity and PureSee IOL
A study testing Phacoemulsification with implantation of an extended depth of focus intraocular lens in people with Cataract, run by OMIQ Research at 1 site in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification with implantation of an extended depth of focus intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jun 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
OMIQ Research
Sant Cugat del Vallès, Barcelona, 08195
Anna Romero, Administration, +34937071936, asdireccio@omiq.es
Mercè Guarro, MD
About this study
Official title: Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
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)
- Conditions
- Cataract
- Being tested
- Phacoemulsification with implantation of an extended depth of focus intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with implantation of an extended depth of focus intraocular lensDevice
Comparison of two different Extended depth of focus intraocular lenses
| Study group | Role | What they receive |
|---|---|---|
| Extended depth of focus intraocular lens Clareon Vivity | Experimental | Not described Receives: Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens |
| Extended depth of focus intraocular lens PureSee | Active comparator | Not described Receives: Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-corrected binocular defocus curve at 4 m
Measured: 3 months
Secondary outcomes (5)
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
Measured: 3 months
Distance-corrected contrast sensitivity
Contrast sensitivity using M\&S device
Measured: Three months
Low contrast (25%) binocular distance-corrected visual acuity
Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts
Measured: 3 months
Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire
Assessment of qualitative visual dysphotopsia using a specific validated questionnaire
Measured: 3 months
Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire
Assessment of recent use of spectacles to see at different distances using a specific questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start27 Jun 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OMIQ Research
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Merce Guarro, OMIQ Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165197
- Sponsor's protocol ID
- VOR2025-HGC-01
- Acronym
- PURVI2
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT07165197
- Acronym / sponsor ID
- PURVI2 / VOR2025-HGC-01
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- OMIQ ResearchResearch network
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended depth of focus intraocular lens Clareon Vivity | Experimental | Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens |
| Extended depth of focus intraocular lens PureSee | Active comparator | Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification with implantation of an extended depth of focus intraocular lensComparison of two different Extended depth of focus intraocular lenses | Device | Extended depth of focus intraocular lens Clareon Vivity, Extended depth of focus intraocular lens PureSee |
Primary outcome
Distance-corrected binocular defocus curve at 4 m
Time frame: 3 months
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification with implantation of an extended depth of focus intraocular lens in people with Cataract, run by OMIQ Research at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance-corrected binocular defocus curve at 4 m (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.