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Clinical Trials/NCT05416177
NCT05416177UnknownNot Applicable

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

Versailles Hospital0 sites31 target enrollmentStarted: September 1, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
31
Primary Endpoint
Distance corrected intermediate monocular visual acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Distance corrected intermediate monocular visual acuity

Time Frame: 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 Outcomes

  • residual astigmatism(months 1 and 3)
  • monocular distance visual acuity(months 1 and 3)
  • binocular uncorrected visual acuity(months 1 and 3)
  • rotational stability(month 3)
  • monocular near visual acuity(months 1 and 3)
  • SIA(month 3)
  • monocular uncorrected intermediate visual acuity(months 1 and 3)
  • questionnaire IOLSAT(month 3)
  • McAlinden questionnaire(month 3)

Investigators

Sponsor
Versailles Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edouard KOCH

Investigator Coordinator

Versailles Hospital

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