Visual Outcomes of Vivity in Patients With High Axial Length

Dr. James J. Wiens Medical Corporation

Status

Completed

Conditions

Cataract

Treatments

Device: Vivity

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05210569

JW-21-001

Details and patient eligibility

About

The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.

Full description

This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Inclusion Criteria:

Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
Gender: Males and Females.
Age: 50 years or older.
Willing and able to provide written informed consent for participation in the study.
Willing and able to comply with scheduled visits and other study procedures.
Motivated for greater degree of spectacle independence vs monofocal IOL.
Axial length ≥24.5mm in both eyes.
Planned cataract removal by femtosecond laser.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

Ocular comorbidity that might hamper postoperative visual acuity.
Previous refractive surgery.
Irregular corneal astigmatism.
Evidence of keratoconus as per Pentacam.
Expected post-op VA worse than 20/25 (Snellen).
Refractive lens exchange.
Difficulties comprehending written or spoken English language.
Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
Axial length <24.5mm.
Evidence of macular pathology as per optical coherence tomography examination.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.