Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 323
- 主要终点
- Correlation between the value of the ITMES score and any silicone oil-related ocular complication
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation between the value of the ITMES score and any silicone oil-related ocular complication
时间窗: Baseline, 1 day, 1 month, 3 months and 6 months
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)
次要结局
- Correlation between the value of the ITMES score and any single types of postoperative silicone oil-related ocular complication(Baseline, 1 day, 1 month, 3 months and 6 months)
- Correlation between the value of the ITMES score and any single types of intraoperative silicone oil-related ocular complication(Baseline, 1 day, 1 month, 3 months and 6 months)
- Correlation between the value of the ITMES score and postoperative retinal attachment(Baseline, 1 day, 1 month, 3 months and 6 months)
- Correlation between the value of the ITMES score and postoperative best-corrected visual acuity(Baseline, 1 day, 1 month, 3 months and 6 months)
研究者
Mario R Romano
Professor
Cliniche Humanitas Gavazzeni