Status:
NOT_YET_RECRUITING
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
Lead Sponsor:
Cliniche Humanitas Gavazzeni
Conditions:
Emulsification of Silicone Oil in Eye Following Surgical Procedure
Eligibility:
All Genders
18+ years
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 silico...
Eligibility Criteria
Inclusion
- One eye requiring pars plana vitrectomy and silicone oil/heavy silicone oil tamponade, OR pars plana vitrectomy and removal of silicone oil/heavy silicone oil OR one silicone-oil filled eye.
Exclusion
- untreated or uncontrolled ocular disease leading to unacceptable higher risk of intra- and post-operative complications, such as uncontrolled ocular inflammation or infection, untreated ocular malignancy and uncontrolled glaucoma;
- uncontrolled severe systemic disease related to significantly higher operative risk;
- pregnant women due to the specific risks related to supine position during surgery, operative time, risks of retrobulbar anesthesia, and intraoperative and postoperative drugs;
- inability to give written consent.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT06198738
Start Date
January 1 2024
End Date
December 1 2024
Last Update
January 18 2024
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