Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary Rhegmatogenous Retinal Detachment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Macular perfusion - SVP
研究概览
简要总结
Rhegmatogenous retinal detachment (RRD) is the separation of the neurosensory retina from the retinal pigment epithelium caused by the presence of a break that leads to the passage of fluid from the vitreous cavity into the potential subretinal space. It is a sight threatening disease, affecting largely people 50 years or older, with an annual incidence varying between 6.3 and 17.9 people per 100,000 population, and is unfortunately increasing. Although other surgical options do exist for the repair of primary RRD, pars plana vitrectomy (PPV) has clear advantages and is certainly effective in the treatment of these patients.
Several agents are used for intraocular tamponade following PPV for RRD. These agents are either silicone oil (SO) or gases like air, perfluoropropane (C3F8), sulfur hexafluoride (SF6), or perfluoroethane (C2F6).
In addition to the complications uniquely peculiar to using SO, research has found out that a reduction in retinal sensitivity on microperimetry was greater in SO tamponade in comparison with gas, as well as poorer visual outcome, microvasculature damage and affection of retinal layers including ganglion cell complex (GCC) in the SO group.
Even though many studies were done to compare between SO and intraocular gas tamponades with respect to many aspects, only one study compared the effects SO had on macular vasculature and anatomy in comparison with air and no study at all to date has compared the SO to SF6 gas in terms of retinal vascular changes, correlating them to thinning of GCC and macular sensitivity, which is precisely the main aim of the current study.
详细描述
Rhegmatogenous retinal detachment (RRD) is the separation of the neurosensory retina from the retinal pigment epithelium (RPE) caused by the presence of a break that leads to the passage of fluid from the vitreous cavity into the potential subretinal space. It is a sight threatening disease, affecting largely people 50 years or older, with an annual incidence varying between 6.3 and 17.9 people per 100,000 population, and is unfortunately increasing. Although other surgical options do exist for the repair of primary RRD, viz. scleral buckling and pneumatic retinopexy, primary pars plana vitrectomy (PPV) has clear advantages and is certainly effective in the treatment of these patients, with a primary success rate of 85%, making it the leading management modality.
Several agents are used for intraocular tamponade following PPV for RRD, in order to provide surface tension across the retinal breaks thus preventing the ingress once more of fluid into the subretinal space, giving time for the permanent seal provided by the retinopexy done whether photocoagulation or cryopexy. These agents are either silicone oil (SO) or gases like air, perfluoropropane (C3F8), sulfur hexafluoride (SF6), or perfluoroethane (C2F6).
In addition to the complications uniquely peculiar to using SO, research has found out that a reduction in retinal sensitivity on microperimetry was greater in SO tamponade in comparison with gas, as well as poorer visual outcome, microvasculature damage and affection of retinal layers including ganglion cell complex (GCC) in the former group leading to the so-called Silicone Oil-Related Visual Loss (SORVL).
Even though many studies were done to compare between SO and intraocular gas tamponades with respect to many aspects, only one study by Zhou et al in 2020 compared the effects SO endotamponade had on macular vasculature and anatomy in comparison with sterilized air tamponade and no study at all to date has compared the SO to SF6 gas in terms of retinal vascular changes, correlating them to thinning of GCC and macular sensitivity, which is precisely the main aim of the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Surgeon will be masked to the tamponading agent (silicone oil or gas) till the end of the operation when either agent will be injected.
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
- •Primary rhegmatogenous retinal detachment
排除标准
- •Macula-on retinal detachment
- •Change of decision of type of endotamponade used intraoperatively
- •Giant retinal tear
- •Proliferative vitreoretinopathy worse than grade B
- •Recent lens surgery within the previous 3 months prior to presentation
- •Prior vitreoretinal surgery
- •Macular hole
- •Signs of epiretinal membrane
- •Diabetic retinopathy
- •Macular degeneration or other macular disorders
- •Inferior retinal breaks between 4 and 8 o'clock
- •History of uveitis
- •History of glaucoma
结局指标
主要结局
Macular perfusion - SVP
时间窗: At 2 and 4 months following primary vitrectomy
Comparison of superficial retinal capillary vascular density between the different treatment arms.
Macular perfusion - FAZ
时间窗: At 2 and 4 months following primary vitrectomy
Comparison of foveal avascular zone area between the different treatment arms as a measure of macular perfusion.
Macular perfusion - DVP
时间窗: At 2 and 4 months following primary vitrectomy
Comparison of deep retinal capillary vascular density between the different treatment arms.
次要结局
- Best corrected visual acuity(At 2 and 4 months following primary vitrectomy)
- Retinal reattachment rate(At 4 months following primary vitrectomy)
- Macular sensitivity(At 2 and 4 months following primary vitrectomy)
- Thickness of ganglion cell complex(At 2 and 4 months following primary vitrectomy)
研究者
Mina Safe Abdelmesih Abdelmalak
Assistant Lecturer
Cairo University