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

August 22, 2022 updated by: Edouard KOCH, Versailles Hospital
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
month 3

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21/21 - VICTOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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