Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •ophthalmologic pathology known other than glaucoma
- •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
研究组 & 干预措施
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.
干预措施: Phacoemulsification (Procedure)
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.
干预措施: Femtolaser surgery (Procedure)
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.
干预措施: Phacoemulsification (Procedure)
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.
干预措施: Femtolaser surgery (Procedure)
结局指标
主要结局
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.
时间窗: within the first 3 months after surgery
次要结局
未报告次要终点