Longitudinal Characterization of Inner Retina Health in Low Vision Retinitis Pigmentosa Patients to Optimize Retinal Ganglion Cell-based Optogenetic Vision Restoration Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Thickness of RNFL thickness in OCT imaging
研究概览
简要总结
The aim of this study is an explorative prospective observation of retinal ganglion cell degeneration and/or inner retina degeneration in Retinitis pigmentosa patients. The rate and patterns of progression will be correlated to the outer retina layers as well as clinical and genetic data of patients. Secondary goal is to determine potential parameters for optogenetic treatment eligibility.
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
- •genetically diagnosed Retintis pigmentosa
- •minimum age of 18 years (legal adult age in Germany)
- •patient consent for study participation
排除标准
- •lack of capacity to consent in participation of study (unconsciousness, mental capacity, mental illness)
- •reduced cooperation during imaging or examination
- •age under 18 years
- •presence of additional retinal diseases
- •insufficient imaging quality due to hazy media (cornea, lense)
结局指标
主要结局
Thickness of RNFL thickness in OCT imaging
时间窗: 6 months intervals, overall time span 5 years
Measuring the thickness of the retinal nerve fiber layer (RNFL) in macular and optic nerve optical coherence tomography (OCT) imaging of the retina.
Thickness of ganglion cell inner plexiforme layer (GCIPL) in OCT imaging
时间窗: 6 months intervals, overall time span 5 years
Measuring the thickness of the ganglion cell inner plexiforme layer (GCIPL) in macula optical coherence tomography (OCT) imaging of the retina.
PD, VD, ICA of the SRP and DRP with OCTA imaging
时间窗: 6 months intervals, overall time span 5 years
Perfusion density (PD), vessel density (VD), intercapillary area size (ICA) of superficial retinal plexus (SRP) and deep retinal plexus (DRP) in OCTA imaging (optical coherence tomography angiography)
Thickness and morphology of inner and outer retinal layers measured with OCT, fundus photography, FAF
时间窗: 6-12 months intervals, overall time span 5 years
Thickness and morphology of inner and outer retinal layers measured with optical coherence tomography (OCT), fundus photography, fundus autofluorescence (FAF)
Changes in functional parameters such as BCVA
时间窗: 6 months intervals, overall time span 5 years
Changes in functional parameters such as best corrected visual acuity
Correlations of outcome 1-5 with clinical data of patients
时间窗: 6 months intervals, overall time span 5 years
Find correlations of imaging outcomes with the clinical data of patients, such as sex, age, age of onset of disease
Correlations of outcome 1-5 with genetic data of patients
时间窗: 6 months intervals, overall time span 5 years
Find correlations of imaging outcomes with the Retinitis pigmentosa mutation and inheritance pattern of patients
Correlation of outcome 1-5 with inflammatory markers
时间窗: 6 months intervals, overall time span 5 years
Correlation of imaging outcomes and disease progression with inflammatory markers collected with serum blood samples and flaremeter as well as slit lamp and fundus examination findings
Correlation of inner and outer retina parameters over time
时间窗: 6 months intervals, overall time span 5 years
Correlation of changes in inner retina and outer retina of collected imaging data over time.
次要结局
未报告次要终点
研究者
Emilie Macé
Professor Dr. Emilie Macé, Department of Ophthalmology, Center of Biostructural Imaging
University Medical Center Goettingen