Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04574102
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2020-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation of Omega Refractive Capsule Model V With Use of an FDA Approved IOL
Sponsor:
Omega Ophthalmics
Organization:
Study Overview
Official Title:
Clinical Investigation of Omega Refractive Capsule, Model V in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2022-04
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:
ORCV
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the
investigational Omega Refractive Capsule (model V)
investigational Omega Refractive Capsule (model V)
Detailed Description:
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design.
Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
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?:
None
Is an FDA AA801 Violation?: