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

Cataract Clinical Trial

— VICTOR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416177
• Other study ID #: P21/21 - VICTOR
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2022
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	month 3
Secondary	residual astigmatism	measure of total residual astigmatism including corneal and internal astigmatism in dioptries	months 1 and 3
Secondary	monocular distance visual acuity	Corrected (BCDVA) and uncorrected monocular distance visual acuity (UCDVA) for the study eye (at 4 m)	months 1 and 3
Secondary	monocular near visual acuity	Corrected (DCNVA) and uncorrected monocular (UCNVA) near visual acuity for the study eye (at 40 cm)	months 1 and 3
Secondary	monocular uncorrected intermediate visual acuity	Uncorrected intermediate visual acuity monocular (UCIVA) for the eye under study (at 66 cm)	months 1 and 3
Secondary	binocular uncorrected visual acuity	Binocular uncorrected visual acuity (UCVA) from far to 4 m, intermediate at 66 cm, near at 40 cm.	months 1 and 3
Secondary	SIA	Surgically induced astigmatism (SIA) and comparison between the 2 hospitals participating in the study	month 3
Secondary	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)	month 3
Secondary	McAlinden questionnaire	questionnaire for the evaluation of visual disturbances (McAlinden): minimum 0/90 and maximum 90/90 (worse outcome)	month 3