Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198738
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-27
Brief Title:
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score CLIN-ITEMS
Sponsor:
Cliniche Humanitas Gavazzeni
Organization:
Cliniche Humanitas Gavazzeni
Study Overview
Official Title:
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score CLIN-ITEMS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
CLIN-ITEMS
Brief Summary:
Prospective multicentric observational study aimed to evaluate the correlation between the value of the InTraocular EMulsion of Silicone oil ITMES score assessed at clinical examination and silicone oil-related ocular complications This will allow to clinically validate the ITEMS score as clinical tool
Demographic data and clinical findings including the ITEMS score of patients undergoing to vitrectomy and silicone oil tamponade or removal of silicone oil or having one silicone oil-filled eye will be collected at the baseline and at each follow-up visit at 1-day 1- 3- and 6-month after surgery
The prognostic performance of the ITEMS score will be evaluated in agreement with the TRIPOD statement
Demographic data and clinical findings including the ITEMS score of patients undergoing to vitrectomy and silicone oil tamponade or removal of silicone oil or having one silicone oil-filled eye will be collected at the baseline and at each follow-up visit at 1-day 1- 3- and 6-month after surgery
The prognostic performance of the ITEMS score will be evaluated in agreement with the TRIPOD statement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None