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

NCT05416177 | Unknown

• 1 other identifier: P21/21 - VICTOR
• Study Type: observational
• Target: 31
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (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

  month 3

Secondary Outcomes (9)

• rotational stability

  month 3

• residual astigmatism

  months 1 and 3

• monocular distance visual acuity

  months 1 and 3

• monocular near visual acuity

  months 1 and 3

• monocular uncorrected intermediate visual acuity

  months 1 and 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordinator

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 13, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08