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临床试验/CTRI/2020/10/028459
CTRI/2020/10/028459招募中不适用

The Incidence of Retinopathy in Rheumatic and Musculoskeletal Disease patients on long term Hydroxychloroquine (HCQ) use - A Prospective Study.

Dr Arindam Nandy Roy1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年10月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
To identify the incidence and risk factors of retinopathy in patients of rheumatic and musculoskeletal diseases using long term HCQ by modern screening methods.

研究概览

简要总结

Hydroxychloroquine (HCQ) is an anti-malarial drug with immune-modulatory properties. It has also shown benefits in treating rheumatic and musculoskeletal diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and scleroderma .The risk of developing irreversible retinopathy and consequent vision loss is a possible serious complication with HCQ use . Modern screening can detect retinopathy early so that necessary dose modification/stoppage of the drug will stop progression of the same. HCQ retinopathy is defined as the presence of a single consistent abnormal test result (in case of HVF-repeated results) with normal findings in others (Possible retinopathy) or presence of definite abnormalities in two tests (one subjective and one objective-Definite retinopathy). In recent times, there is no prospective study to identify the incidence of this retinopathy though retrospective studies are available. The prevalence of retinopathy in long term use patients appears to be around 7.5% at 5 years .

Baseline Examination: All the demographic factors such as age, gender, height, weight, BMI, history of diabetes, hypertension and other systemic diseases and medications will be taken. Preliminary Vision testing & refraction, intraocular pressure recording, slit lamp biomicroscopy will be done to rule out any anterior segment anomalies followed by 90D fundus examination. Retinopathy secondary to diabetes, hypertension,  age related macular degeneration, glaucoma and other retinopathies will be excluded by fundoscopy. OCT, field analysis and other investigations will be done wherever necessary by the ophthalmologist.

Annual Screening: Annual screening examinations will include automated HVF (24-2) and SD-OCT with optional fundus autofluorescence (FAF) and/or multifocal electroretinogram (mfERG) as needed.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Able to provide signed consent form.
  • Subjects clinically diagnosed to have rheumatic and musculoskeletal diseases.
  • Subjects willing to take HCQ for long duration.

排除标准

  • Preexisting ocular conditions of the anterior segment or the retina causing defective vision.
  • Are taking a medication other than HCQ with retinotoxic side effects (Tamoxifen).
  • Known hypersensitivity to 4-aminoquinoline compounds (such as Chloroquine or hydroxychloroquine).
  • Previous exposure to HCQ.

结局指标

主要结局

To identify the incidence and risk factors of retinopathy in patients of rheumatic and musculoskeletal diseases using long term HCQ by modern screening methods.

时间窗: After 01 year( later each year )

次要结局

  • Skin hyper pigmentation(after 06 months)

研究者

发起方
Dr Arindam Nandy Roy
申办方类型
Other [self]

研究点 (1)

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