Clinical trial NCT06198738: Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
Official title: Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emulsification of Silicone Oil in Eye Following Surgical Procedure
Lead sponsor: Cliniche Humanitas Gavazzeni
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients meeting the inclusion criteria

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.


Eligibility 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.

Primary outcomes:
measure: Correlation between the value of the ITMES score and any silicone oil-related ocular complication
timeFrame: Baseline, 1 day, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Correlation between the value of the ITMES score and any single types of intraoperative silicone oil-related ocular complication
timeFrame: Baseline, 1 day, 1 month, 3 months and 6 months
measure: Correlation between the value of the ITMES score and any single types of postoperative silicone oil-related ocular complication
timeFrame: Baseline, 1 day, 1 month, 3 months and 6 months
measure: Correlation between the value of the ITMES score and postoperative retinal attachment
timeFrame: Baseline, 1 day, 1 month, 3 months and 6 months
measure: Correlation between the value of the ITMES score and postoperative best-corrected visual acuity
timeFrame: Baseline, 1 day, 1 month, 3 months and 6 months
Other outcomes:
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