Trials / Unknown
UnknownNCT06198738
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 323 (estimated)
- Sponsor
- Cliniche Humanitas Gavazzeni · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2024-01-10
- Last updated
- 2024-01-18
Source: ClinicalTrials.gov record NCT06198738. Inclusion in this directory is not an endorsement.