Ganglion Cell Complex thickness in Indian Patients on Hydroxychloroquine and its Correlation with Vessel Density on OCTA – A comparative cross-sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the thickness of Ganglion cell complex at the macula in patients taking HCQ
研究概览
简要总结
Hydroxychloroquine (HCQ) retinopathy is a known side effect of long term administration of HCQ. Predisposing risk factors area daily dose more than 6.5 mg/kg, cumulative dose more than 1000 g, duration of use over 5 years
In the initial phase, toxicity is reversible after drug discontinuation
However, with current Objective Imaging techniques, irreversible RPE changes have occurred and some degree of visual loss is evident.
Therefore, early detection is critical.
Increasing evidence exists, of signs of HCQ toxicity in RGC before visual loss occurs before morphological changes occur in the outer retinal layers which are irreversible. GCL complex not studied in Asian patients. While effect of HCQ on vessel density on OCT angiography (OCTA) has been studied, its correlation with GCL thickness has not been studied before. Our study aims to observe the thinning of ganglion cell complex in Asian patients taking HCQ as an early objective sign of toxicity before retinopathy develops.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •patients on HCQ treatment for any rheumatological or dermatological disorder with refractive error less than or equal to +/- 4D and cylinder of less than or equal to -3D with an intraocular pressure measurement of less than 21 mmHg.
排除标准
- •patients diagnosed to have HCQ retinopathy or having systemic diseases like Hypertension, kidney disorder or diabetes mellitus .
- •patients having retinal pigment epithelial abnormalities , or media opacities, glaucoma, preexisting retinal pathology or paracentral scotomas on visual field testing and patients having colour vision defects.
结局指标
主要结局
To study the thickness of Ganglion cell complex at the macula in patients taking HCQ
时间窗: at baseline
次要结局
- Correlation of GCC Thickness with vessel density changes in SCP & DCP layer in OCTA.(To study correlation of GCC thickness with cumulative dose of HCQ.)
研究者
Dr Minija CK
Sankara Eye Hospital, Bengaluru