Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483750
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease
Detailed Description:
Eligible patients to be recruited will have scheduled upcoming senile cataract surgery Enrolled patients in the active arm n25 will receive pre-operative Systane iLux treatment two weeks prior to surgery at the baseline visit Patients in the control arm will receive no Systane iLux treatment at the baseline visit two weeks prior to cataract surgery Patients will be assessed on baseline metrics for dry eye disease stemming and meibomian gland dysfunction MGD at the baseline visit two weeks prior to cataract surgery These metrics include tear break up time TBUT standard patient evaluation of eye dryness questionnaire SPEED ocular surface and surface disease index OSDI surveys and lipid layer thickness LLT At the follow up visit four weeks after cataract surgery these same metrics will be assessed again for any significant changes
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