Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-02 @ 2:04 PM
Study NCT ID:
NCT05210569
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Outcomes of Vivity in Patients With High Axial Length
Sponsor:
Dr. James J. Wiens Medical Corporation
Organization:
Study Overview
Official Title:
Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: