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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the value of the ITMES score and any silicone oil-related ocular complication | The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376) | Baseline, 1 day, 1 month, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the value of the ITMES score and any single types of intraoperative silicone oil-related ocular complication | The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376) |
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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:
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All adult patients meeting the inclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario R Romano, MD PhD | Contact | +39 035 283511 | mario.romano.md@gmail.com | |
| Mariantonia Ferrara, MD | Contact | +39 035 283511 | mariantonia.ferrara@gmail.com |
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| Baseline, 1 day, 1 month, 3 months and 6 months |
| Correlation between the value of the ITMES score and any single types of postoperative silicone oil-related ocular complication | The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376) | Baseline, 1 day, 1 month, 3 months and 6 months |
| Correlation between the value of the ITMES score and postoperative retinal attachment | The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376) | Baseline, 1 day, 1 month, 3 months and 6 months |
| Correlation between the value of the ITMES score and postoperative best-corrected visual acuity | The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376) | Baseline, 1 day, 1 month, 3 months and 6 months |