Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863742
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-22
Brief Title:
Evaluation Of Vision Recovery And Comfort Index In Patients With BorderlineMild Dry Eyes Undergoing FLACS With Premium IOL
Sponsor:
Sight Medical Doctors PLLC
Organization:
Sight Medical Doctors PLLC
Study Overview
Official Title:
Evaluation Of Vision Recovery And Comfort Index In Patients With BorderlineMild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
ENHANCE
Brief Summary:
This is a prospective open-label single-center randomized head-to-head investigator-sponsored clinical study It aims to investigate the vision recovery and patient comfort in borderlinemild dry eye disease patients undergoing FLACS with Premium PCIOL ie Panoptix Toric IOL sphericalmultifocal ReStor Symfony receiving a 04mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1
Detailed Description:
This is a prospective open-label single-center randomized head-to-head investigator-sponsored clinical study It aims to investigate the vision recovery and patient comfort in borderlinemild dry eye disease patients undergoing FLACS with Premium PCIOL ie Panoptix Toric IOL sphericalmultifocal ReStor Symfony receiving a 04mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1 After screening a given patient for inclusion and exclusion criteria and gaining informed consent a total of 30 patients will be randomized into two groups
Group 1 15 patients will undergo bilateral FLACS Premium PCIOL in separate days and will receive a 04mg dexamethasone intracanalicular insert at the days of each surgery
Group 2 15 patients will undergo bilateral FLACS Premium PCIOL in separate days and will receive prednisolone acetate 1 QID 1 week TID 1 week BID1 week QD 1 week regimen starting at the days of each surgery
All patient eyes will receive Prolensa 007 ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 06 eye drops TIDstarting 3 days prior to surgery
Per enrolled eye the study period will last for approximately 30 days after surgery consisting of three postop follow-up visits six total postop visits per patient At Day 1 Day 7 and Day 30 primary and secondary endpoints will be assessed alongside standard-of-care procedures SPEED questionnaire will be assessed by a masked survey administrator Adjusting for enrollment period the study will last a total of approximately 12 months including submission for publication presentation
Group 1 15 patients will undergo bilateral FLACS Premium PCIOL in separate days and will receive a 04mg dexamethasone intracanalicular insert at the days of each surgery
Group 2 15 patients will undergo bilateral FLACS Premium PCIOL in separate days and will receive prednisolone acetate 1 QID 1 week TID 1 week BID1 week QD 1 week regimen starting at the days of each surgery
All patient eyes will receive Prolensa 007 ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 06 eye drops TIDstarting 3 days prior to surgery
Per enrolled eye the study period will last for approximately 30 days after surgery consisting of three postop follow-up visits six total postop visits per patient At Day 1 Day 7 and Day 30 primary and secondary endpoints will be assessed alongside standard-of-care procedures SPEED questionnaire will be assessed by a masked survey administrator Adjusting for enrollment period the study will last a total of approximately 12 months including submission for publication presentation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None