Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- • Change in PFT after SOR
研究概览
简要总结
Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.
详细描述
Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.
After checking inclusion and exclusion criteria; we will enroll all the cases.
We shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (Cohort).
- Group A: 3 months SO Tamponade
- Group B: 6 months SO Tamponade
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Silicone oil (SO) tamponade ( up to 6 months)
- •Attached retina under SO
- •Attached retina 3 months after Silicone oil Removal (SOR)
- •Normal fellow eye ( no retinal detachment or macular disease)
- •OCT scan performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)
排除标准
- •• Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)
- •SO tamponade less than 3 months, or more than 6 months
- •Recurrent RD under SO
- •Recurrent RD within 3 months after SOR
- •Vitrectomized fellow eye
- •Retinal detachment, or macular disease in the fellow eye.
- •Posterior staphyloma
- •Anisometropia (history, refraction if possible, spectacles prescription)
- •Absence of any of the OCT scans performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)
结局指标
主要结局
• Change in PFT after SOR
时间窗: from baseline fellow eye to 1 month after silicone oil removal
• Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)
• Change in CFT after SOR
时间窗: from baseline fellow eye to 1 month after silicone oil removal
• Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)
Change in CFT just before SOR (central foveal thickness)
时间窗: baseline to time just before silicone oil removal
Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)
Change in PFT just before SOR (Parafoveal thickness)
时间窗: baseline to time just before silicone oil removal
Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)
次要结局
- • Relative Risk of severe PFT Thinning before SOR (between group A and B(baseline to time just before silicone oil removal)
- • Relative Risk of severe CFT Thinning after SOR (between group A and B)(from baseline fellow eye to 1 month after silicone oil removal)
- • Relative Risk of severe CFT Thinning before SOR (between group A and B)(baseline to time just before silicone oil removal)
- • Relative Risk of severe PFT Thinning after SOR (between group A and B)(from baseline fellow eye to 1 month after silicone oil removal)
研究者
Wael Ahmed Ewais
Associate Professor of Ophthalmology Cairo university
Dar El Oyoun Hospital