Efficacy of intravitreal dexamethasone injection in chronic, atypical, and recurrent central serous chorioretinopathy. A prospective pilot study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in intraocular pressure
研究概览
简要总结
Background: Central serous chorioretinopathy (CSC), characterized by an idiopathic serous neurosensory retinal detachment, has unclear pathogenesis. Choroidal hyperpermeability and retinal pigment epithelial (RPE) dysfunction have been suggested as possible mechanisms. While the benign nature of acute CSC is known, treatment challenges remain for chronic, atypical, and recurrent central serous chorioretinopathy because persistent fluid at macula results in permanent RPE damage and consequent vision loss. Treatment aims to preserve the outer neurosensory retinal layers and achieve complete resolution of the subretinal fluid (SRF) and intraretinal fluid (IRF), as even a tiny amount of remaining SRF can lead to irreversible damage to photoreceptors.
Both thermal and photochemical lasers like photodynamic therapy (PDT) have been advocated for treating these eyes. Chronic CSC (cCSC) with broad and indistinct leakage where thermal lasers are believed to be more damaging, PDT proves to be safer and efficacious in reducing SRF and improving visual acuity. But the non-availability of Verteporfin has forced retina surgeons to damaging thermal lasers in recent times. While both the interventions may result in RPE atrophy, PDT, in addition, may cause choroidal hypoperfusion and neovascular complications. Subthreshold lasers have also been tried in cCSC, but the need for confluent treatment spots in the absence of visible burns is a challenge.
Rationale: Dexamethasone has the highest relative clinical efficacy of any corticosteroid applied to ophthalmology practice and exerts its’ multiple effects via its’ influence on numerous signal transduction pathways. It has been approved for treating macular edema in retinal venous occlusions and non-infectious uveitis. Studies of diabetic macular edema treatment have demonstrated that dexamethasone implant may be an alternative treatment in recalcitrant edema owing to its’ anti-inflammatory, anti-permeability, and angiostatic effects. In age-related macular degeneration, anti-VEFG resistant choroidal neovascular complications responded well to a combination treatment of dexamethasone and anti-VEGF by improving retinal fluid resorption. CSC, a disease in which patients are advised to avoid corticosteroids in all forms anecdotal reports of Intravitreal triamcinolone injection have reported equivocal results. Intravitreal triamcinolone in chronic CSC, in a single case report, Jonas et al. did not find marked benefit, but Patron et al. showed complete resolution of cystoid changes secondary to cCSC.As dexamethasone implant as a rescue treatment in cCSC has never been tried in a prospective clinical study, we intend to determine its’ efficacy in chronic, atypical and recurrent central serous chorioretinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 46.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with non-resolving and recurrent CSCR with focal, multifocal, or diffuse leaks on FA
- •Eyes with focal leaks within 1000microns of the center of fovea in chronic CSCR
- •Best corrected vision score of 73 to 34 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20/40 to 20/200)
- •Decrease in vision primarily secondary to CSCR
- •Willing to sign informed consent form.
排除标准
- •Laser or pharmacological treatment for CSCR in previous six months
- •Eyes with choroidal neovascularization demonstrated on OCTA/FA/ICGA
- •Fellow eye vision worse than 20/200
- •Patients with glaucoma.
结局指标
主要结局
Change in intraocular pressure
时间窗: 6 and 12 weeks
Complete resolution of SRF as determined on OCT
时间窗: 6 and 12 weeks
The disappearance of intraretinal cystoid spaces
时间窗: 6 and 12 weeks
Visual acuity change
时间窗: 6 and 12 weeks
Change in contrast sensitivity
时间窗: 6 and 12 weeks
Change in mfERG waveforms
时间窗: 6 and 12 weeks
次要结局
- Reappearance of disease(% Requiring retreatment)
