Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05739656
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2023-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Visual Acuity of the Envista One-piece Acrylic Toric IOL MX60ET
Sponsor:
Bausch & Lomb Incorporated
Organization:
Study Overview
Official Title:
A PROSPECTIVE, MULTICENTER, POST-MARKET OBSERVATIONAL STUDY TO EVALUATE ROTATIONAL STABILITY AND FUNCTIONAL VISUAL ACUITY OF THE ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC TORIC IOL MX60ET FOLLOWING CATARACT SURGERY PROTOCOL.
Status:
COMPLETED
Status Verified Date:
2023-01
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 primary objective of this study is to evaluate rotational stability and functional improvements in visual acuity of the enVista monofocal Toric IOL (MX60ET) following cataract surgery.
Detailed Description:
This is a prospective, multicenter, post-market observational study at approximately 5 sites in the United States. All clinical sites will have Institutional Review Board (IRB) approval prior to recruiting potential subjects. All subjects who meet eligibility criteria will be consecutively offered enrollment into the trial. Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in one or both eyes at up to 5 clinical sites in the United States. For subjects with pre-existing cataracts in both eyes requiring removal and IOL implantation, the eye with the worse BCDVA at the preoperative visit will be designated the study eye. If BCDVA is the same for both eyes, the right eye will be designated the study eye. Postoperatively, all subjects will undergo ophthalmic examinations at regular intervals per the study visit schedule through Form 4 (120-180 days postoperative).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: