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

Sponsor
Versailles Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05416177
Collaborator
(none)
31
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    31 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Vivity With French Clinical Data Related to the Toric Model Study
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Distance corrected intermediate monocular visual acuity [month 3]

      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

    Secondary Outcome Measures

    1. rotational stability [month 3]

      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

    2. residual astigmatism [months 1 and 3]

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

    3. monocular distance visual acuity [months 1 and 3]

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

    4. monocular near visual acuity [months 1 and 3]

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

    5. monocular uncorrected intermediate visual acuity [months 1 and 3]

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

    6. binocular uncorrected visual acuity [months 1 and 3]

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

    7. SIA [month 3]

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

    8. questionnaire IOLSAT [month 3]

      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)

    9. McAlinden questionnaire [month 3]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Versailles Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edouard KOCH, Investigator Coordinator, Versailles Hospital
    ClinicalTrials.gov Identifier:
    NCT05416177
    Other Study ID Numbers:
    • P21/21 - VICTOR
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Aug 25, 2022