Visual Outcomes of Vivity in Patients With High Axial Length

Cataract Clinical Trial

Official title:

Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210569
• Other study ID #: JW-21-001
• Status: Completed
• Start date: January 13, 2022
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: Dr. James J. Wiens Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Vivity
Vivity intraocular lens (IOL)

Locations

Country	Name	City	State
Canada	Image Plus Laser Eye Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Dr. James J. Wiens Medical Corporation	Sengi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected distance visual acuity	Binocular uncorrected distance visual acuity	3 months
Primary	Binocular uncorrected intermediate visual acuity	Binocular uncorrected intermediate visual acuity	3 months
Primary	Binocular uncorrected near visual acuity	Binocular uncorrected near visual acuity	3 months
Secondary	Prediction error	Percentage of eyes with absolute prediction error of 0.5D or less	3 months
Secondary	Binocular best-corrected distance visual acuity	Binocular best-corrected distance visual acuity	3 months
Secondary	Binocular best-corrected intermediate visual acuity	Binocular best-corrected intermediate visual acuity	3 months
Secondary	Binocular best-corrected near visual acuity	Binocular best-corrected near visual acuity	3 months
Secondary	Monocular best-corrected distance visual acuity	Monocular best-corrected distance visual acuity	3 months
Secondary	Monocular best-corrected intermediate visual acuity	Monocular best-corrected intermediate visual acuity	3 months
Secondary	Monocular best-corrected near visual acuity	Monocular best-corrected near visual acuity	3 months
Secondary	Manifest refraction	Residual spherical equivalent refraction, residual sphere, and residual astigmatism	3 months
Secondary	Questionnaire	Questionnaire for visual disturbance scores (QUVID)	3 months
Secondary	Questionnaire	Patient satisfaction questionnaire scores (IOLSAT)	3 months
Secondary	Binocular distance-corrected low contrast distance visual acuity	Binocular distance-corrected low contrast distance visual acuity	3 months