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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05210569
Other study ID # JW-21-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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