Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
研究概览
简要总结
This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
详细描述
The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 40 years
- •diagnosis of pituitary adenoma
- •treatment-naïve with Endoscopic Endonasal Pituitary Surgery
- •absence of other neurological diseases
- •absence of vitreoretinal and vascular retinal diseases
排除标准
- •age younger than 40 years
- •No diagnosis of pituitary adenoma
- •previous treatments with Endoscopic Endonasal Pituitary Surgery
- •presence of neurological diseases
- •presence of vitreoretinal and vascular retinal diseases
结局指标
主要结局
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
时间窗: 48 hours and 1 year follow up
8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
时间窗: 48 hours and 1 year follow up
8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
次要结局
- Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery(1 year follow up)
- Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery(1 year follow up)
研究者
Gilda Cennamo
Principal Investigator
Federico II University