Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 1:49 AM
Study NCT ID:
NCT05827133
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation
Sponsor:
East Coast Institute for Research
Organization:
Study Overview
Official Title:
A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation
Status:
COMPLETED
Status Verified Date:
2024-08
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 goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
* consent to participate in the study
* allow researchers to access their personal medical records
* undergo a series of tests to assess the position of their IOLs and quality of vision
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
* consent to participate in the study
* allow researchers to access their personal medical records
* undergo a series of tests to assess the position of their IOLs and quality of vision
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
Detailed Description:
This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.
Study Oversight
Has Oversight DMC:
None
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?: