Biomarkers for Prognosis in Different Forms of Retinitis Pigmentosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Retinal pigment epithelium changes in Retinitis Pigmentosa.
研究概览
简要总结
The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.
详细描述
After a genetic confirmation of RP and classification, the patients will undergo a comprehensive ophthalmological examination that includes the following tests: slit-lamp anterior segment, visual acuity direct and indirect ophthalmoscopy, intraocular pressure, and family history.In order to evaluate the potential role of RPE in the advancement of RP, HD-OCT and OCT angiography images of the outer retina using OCT devices will be performed.
Analysis of high-resolution images captured with an ultrawidefield system using a Zeiss Clarus device in order to determine the condition of the peripheral retina.Finally, Flicker Electroretinogram (fERG) performed on the central retina (macula), to assess the central macular function within an 18° field of view. This assessment involved measuring the response of the macula to a flickering stimulus with a frequency of 41 Hz, which is commonly done in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who are able to read and sign informed consent
- •Patients with Retinitis pigmentosa confirmed by genetic test.
- •Patients older than or equal to 18 years of age
排除标准
- •Other retinal diseases such as macular hole, retinal detachment, macular neovascularization.
- •Corneal surgery in the last 12 months
- •Glaucoma with pressure above 25 mmHg in the last three months.
- •Best Correct Visual Acuity below 1/10 in at least one eye.
结局指标
主要结局
Retinal pigment epithelium changes in Retinitis Pigmentosa.
时间窗: 14 months
Retinal pigment epithelium extent measured with OCT calliper (micrometers).
次要结局
- Retinitis Pigmentosa biomarkers(14 months)
研究者
RIZZO STANISLAO
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS