NCT03351894已完成不适用
Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Cumulative dissipated energy (CDE)
研究概览
简要总结
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery
详细描述
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery. This study will be a non-inferiority study and ninety-five patients will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A cataract will be defined as clouding of the lens that interferes with normal vision.
- •Not relevant, as study not on cancer patients.
- •Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- •Only individuals with the mental capacity to provide informed consent with be included.
- •More specifically, all the following inclusion criteria must be met:
- •Patients have medically dilated pupil size of at least 4.0mm.
- •Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- •Patients are willing and able to return for scheduled follow-up examinations for 12 months after the cataract surgery.
排除标准
- •Patients with prior history of pseudoexfoliation syndrome.
- •Patients with a prior history of glaucoma filtration surgery.
- •Patients with optic atrophy.
- •Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event..
- •Patients with a prior history of vitrectomy.
- •Patients with a prior history of cataract or refractive lens surgery
- •Patients with central corneal scarring.
- •Patients with residual, recurrent, active or uncontrolled eyelid disease.
- •Patients with significant corneal asymmetry or irregular topography.
- •Patients with anterior segment pathology.
- •Patients with any corneal abnormality
- •Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- •Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
- •Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
结局指标
主要结局
Cumulative dissipated energy (CDE)
时间窗: 12 months
Energy from phaco machine
次要结局
- Refraction (diopters)(12 months)
- Optic disc nerve(OCT)(12 months)
- Anterior chamber inflammation (by flaremeter)(12 months)
- Intraocular pressure (mmHg)(12 months)
- Patient surgery experiences (questionnaire)(12 months)
- Effective intraocular lens position (UBM)(12 months)
- Corneal endothelial count(12 months)
- Best corrected distance visual acuity (snellen)(12 months)
研究者
Jodhbir Mehta
Senior consultant
Singapore Eye Research Institute
研究点 (2)
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