Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)

Cliniche Humanitas Gavazzeni

Status: Not yet enrolling

Conditions: Emulsification of Silicone Oil in Eye Following Surgical Procedure

Study type: Observational

Funder types: Other

Identifiers

NCT06198738

344/23

Details and patient eligibility

About

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.

Enrollment: 323 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 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 Criteria:

• 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.