Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-01 @ 9:19 AM
Study NCT ID:
NCT04523558
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs
Sponsor:
Gemini Eye Clinic
Organization:
Study Overview
Official Title:
Evaluation of the Extended Depth of Focus After Bilateral Implantation of a Hydrophobic IOL With a New Optic Concept Based on a Combination of High Order Aberrations
Status:
COMPLETED
Status Verified Date:
2023-04
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:
LuxSmart
Brief Summary:
This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch \& Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.
The device under investigation LuxSmart (Bausch \& Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.
Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.
The device under investigation LuxSmart (Bausch \& Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: