Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118944
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Brief Title:
Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
Sponsor:
University of Trieste
Organization:
University of Trieste
Study Overview
Official Title:
Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile a Randomized Controlled Clinical Study
Status:
COMPLETED
Status Verified Date:
2023-10
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:
RCT_ICB00
Brief Summary:
To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens IOL with two different monofocal IOLs in patients scheduled for bilateral cataract surgery
Detailed Description:
The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively
The ICB00 IOL is a modified monofocal IOL Compared to other monofocal IOLs its modified optical design was created to provide improved intermediate vision comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses
Considering the modified optical profile of the ICB00 IOL the primary objective will be the evaluation of visual performance at intermediate distance
The ICB00 IOL is a modified monofocal IOL Compared to other monofocal IOLs its modified optical design was created to provide improved intermediate vision comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses
Considering the modified optical profile of the ICB00 IOL the primary objective will be the evaluation of visual performance at intermediate distance
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?:
True
Is an FDA AA801 Violation?:
None