Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery (FEMTOHTO)
The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).
If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.
No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.
Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.
The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Paris、法国、75019
- Fondation ophtalmique Adolphe de Rothschild
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- scheduled bilateral cataract surgery
- bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).
Exclusion Criteria:
- ophthalmologic pathology known other than glaucoma
diabetes
- untreated hypertension
- multiple sclerosis
- Graves' disease
- sarcoidosis
- patient taking toxic drug for the optic nerve and the retina
- neurodegenerative disease
- all general diseases that can affect the ocular structures
- eye surgery history
- patient's opposition to participation in the study, according to the law on research into routine care
- absence of affiliation to social security or to universal medical coverage
- legally protected patient
- pregnancy or breastfeeding
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Patient with glaucoma
Patient eligible for bilateral cataract surgery, with glaucoma.
Each patient is his own control.
The patient is treated with femtolaser surgery for one eye and with phacoemulsification for the other eye.
|
|
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其他：Patient without glaucoma
Patient eligible for bilateral cataract surgery, without glaucoma.
Each patient is his own control.
The patient is treated with femtolaser surgery for one eye and with the phacoemulsification for the other eye.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.
大体时间：within the first 3 months after surgery
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within the first 3 months after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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