AzTrials
AzTrials

CataractVICTORNCT05416177

Assessment of Vivity With French Clinical Data Related to the Toric Model Study

An observational study of Cataract, run by Versailles Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Presbyopia-correcting implant (PC-IOL): AcrySof IQ Vivity (Alcon) has been evaluated in 2 large pivotal trials (US and OUS trials). These tests showed that this PC-IOL restored intermediate visual acuity (IVA) and near visual acuity (NV A) superior to that of the reference monofocal AcrySof implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
How many people
31 participants
Where
2 sitesFrance
Study dates
9 Sep 2022to 12 Jul 2024
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be selected from among patients who come for consultation for cataract surgery. During the inclusion visit, the doctor will inform the patients eligible for the study, and answer all their questions about the objective, the constraints, the foreseeable risks and the expected benefits of the study. Without opposition from the patient, the doctor will perform the cataract surgery and the data will be collected on D0, M1 and M3.

Who may be able to join

  • Patient presenting for a request for cataract surgery in current practice: phacoemulsification followed by classic implantation of an IOL with small incision size (< 2.2mm)
  • Calculated power of IOL is between 10.0 and 30.0 diopters (D) in 0.5D steps to target emmetropia (0.0 +/- 0.5D)
  • Patients with corneal astigmatism > 0.5D and who can receive an implant with a toricity between T2 and T6, i.e. with astigmatism between +0.5D and +2.5D.
  • If both eyes have astigmatism, the eye under study will be the right eye
  • Patient having been informed and not objecting to their participation.

Who cannot join

  • Pregnancy or breastfeeding while conducting the study
  • Person under the age of 18
  • History of pathologies of the anterior segment of the eye (cornea, anterior chamber, sulcus) or posterior segment of the eye (uvea, vitreous, retina) including retinal vascular occlusions, retinal detachment, peripheral retinal laser photocoagulation, AMD and glaucoma
  • Any inflammation of the anterior or posterior segment, whatever its etiology or history of disease, which may lead to an inflammatory reaction
  • Clinically significant corneal pathology (epithelial, stromal, or endothelial that could affect visual outcome)
  • Clinically significant severe dry eye disease that may affect visual calculations and measurements
Show all 11Show fewer
  • History of refractive surgery
  • Amblyopia or monofixation syndrome
  • Patient at risk of zonular rupture during the phacoemulsification procedure and may affect the centering or tilt of the implant postoperatively.
  • Irregular astigmatism (corneal topography)
  • Any other planned eye surgery

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CH de Versailles

    Le Chesnay, 78150

  • Hôpital Cochin

    Paris, 75

Other trials in France

About this study

Presbyopia-correcting implant (PC-IOL): AcrySof IQ Vivity (Alcon) has been evaluated in 2 large pivotal trials (US and OUS trials). These tests showed that this PC-IOL restored intermediate visual acuity (IVA) and near visual acuity (NV A) superior to that of the reference monofocal AcrySof implant. In these tests, it was demonstrated that distance visual acuity (DVA) was non-inferior. However, the intermediate visual acuity for this implant in its toric version has not been evaluated.

Conditions
Cataract
Medical subject headings
Cataract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance corrected intermediate monocular visual acuity

    Intermediate monocular visual acuity (at 66 cm) corrected for distance vision (DCIVA) for the eye under study in photopic condition (normal lighting) 3 months after implantation of the 2nd eye

    Measured: month 3

Secondary outcomes (9)

  1. rotational stability

    Rotational stability of the IOL in the eye under study expressed in degree of rotation at 3 months compared with that collected just after surgery in the operating room

    Measured: month 3

  2. residual astigmatism

    measure of total residual astigmatism including corneal and internal astigmatism in dioptries

    Measured: months 1 and 3

  3. monocular distance visual acuity

    Corrected (BCDVA) and uncorrected monocular distance visual acuity (UCDVA) for the study eye (at 4 m)

    Measured: months 1 and 3

  4. monocular near visual acuity

    Corrected (DCNVA) and uncorrected monocular (UCNVA) near visual acuity for the study eye (at 40 cm)

    Measured: months 1 and 3

  5. monocular uncorrected intermediate visual acuity

    Uncorrected intermediate visual acuity monocular (UCIVA) for the eye under study (at 66 cm)

    Measured: months 1 and 3

  6. binocular uncorrected visual acuity

    Binocular uncorrected visual acuity (UCVA) from far to 4 m, intermediate at 66 cm, near at 40 cm.

    Measured: months 1 and 3

  7. SIA

    Surgically induced astigmatism (SIA) and comparison between the 2 hospitals participating in the study

    Measured: month 3

  8. questionnaire IOLSAT

    questionnaire for addiction to glasses for intermediate vision and near vision (IOLSAT) : minimum 0% (no glasses needed, best outcome), to maximum 100% (glasses needed, worse outcome)

    Measured: month 3

  9. McAlinden questionnaire

    questionnaire for the evaluation of visual disturbances (McAlinden): minimum 0/90 and maximum 90/90 (worse outcome)

    Measured: month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start9 Sep 2022
  3. Primary completion9 Apr 2024
  4. Study completion12 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
31 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416177
Sponsor's protocol ID
P21/21 - VICTOR
Acronym
VICTOR
Status last verified
Sep 2026
First submitted
3 Jun 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Koch E, Morel M, Duchateau N. Assessment of vivity with French clinical data related to the toric model study. Sci Rep. 2025 Nov 19;15(1):40691. doi: 10.1038/s41598-025-23939-3.

    PubMed 41258182

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Versailles Hospital at 2 sites in France.

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 5 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance corrected intermediate monocular visual acuity (time frame: month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416177, which also lists 1 linked publication.

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 1 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in