Visual Outcomes of Vivity in Patients With High Axial Length

Completed

Conditions: Cataract

Interventions: Device: Vivity

Registration Number: NCT05210569

Lead Sponsor: Dr. James J. Wiens Medical Corporation

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral implantation of the Vivity IOL	Vivity	Vivity intraocular lens (IOL)

Primary Outcome Measures

Name	Time	Method
Binocular Uncorrected Distance Visual Acuity (logMAR)	3 months postoperatively	Binocular uncorrected distance visual acuity (logMAR)
Binocular Uncorrected Intermediate Visual Acuity (logMAR)	3 months postoperatively	Binocular uncorrected intermediate visual acuity (logMAR)
Binocular Uncorrected Near Visual Acuity (logMAR)	3 months postoperatively	Binocular uncorrected near visual acuity (logMAR)

Secondary Outcome Measures

Name	Time	Method
Binocular Distance Corrected Near Visual Acuity (logMAR)	3 months postoperatively	Binocular distance corrected near visual acuity (logMAR)
Prediction Error	3 months postoperatively	Percentage of eyes with absolute prediction error of 0.5D or less
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)	3 months postoperatively	Binocular distance-corrected low contrast distance visual acuity (logMAR)
Binocular Corrected Distance Visual Acuity (logMAR)	3 months postoperatively	Binocular corrected distance visual acuity (logMAR)
Manifest Refraction Spherical Equivalent	3 months postoperatively	Manifest refraction spherical equivalent
Questionnaire	3 months postoperatively	Questionnaire for visual disturbance scores (QUVID)
Percentage of Participants With Spectacle Independence	3 months	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)	3 months postoperatively	Binocular distance corrected intermediate visual acuity (logMAR)
Monocular Corrected Distance Visual Acuity (logMAR)	3 months postoperatively	Monocular corrected distance visual acuity (logMAR)
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)	3 months postoperatively	Monocular distance corrected intermediate visual acuity (logMAR)
Monocular Distance Corrected Near Visual Acuity (logMAR)	3 months postoperatively	Monocular distance corrected near visual acuity (logMAR)