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

NCT ID: NCT05416177

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-07-01

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.

Conditions

Cataract

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Edouard KOCH

Investigator Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P21/21 - VICTOR

Identifier Type: -

Identifier Source: org_study_id