NCT01382641Unknown4 期
Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measuring Ocular Dominance
研究概览
简要总结
The doctors participating in this study are looking to show improved vision with the HOYA AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of Revital Vision (neuro-sensory testing) in providing the highest potential for improved vision.
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
- None
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
- •Patients must desire to pursue some type of mono-vision fit, mono-vision lasik, or mono-vision cataract surgery with lens implant.
- •Patients must be candidates for intraocular lens implantation for the correction of aphakia following extracapsular cataract extraction by phaco-emulsification.
- •Patients must be candidates for bilateral implantation and desiring post-operative spectacle independence through targeted mono-vision.
- •Patients must have less than 1.50 diopters of corneal astigmatism
- •Patients must have the potential for best corrected visual acuity of 20/30 or better in each eye.
- •Patients must have the mental capacity to cooperate when undergoing a detailed postoperative refractive examination.
- •Patients must be an adult.
- •Patients must provide written informed consent for cataract surgery.
- •Patients must be willing and able to return for scheduled follow-up examinations for a period of 3 months (post-second eye) post-operatively.
- •Patients must be willing and able to provide feedback to various survey questions regarding overall satisfaction and ease of adaptation to mono-vision and range of vision, etc.
排除标准
- •Patients with 1.50 diopters or more of corneal astigmatism
- •Patients requiring a lens power less than 6 D or greater than 30 D
- •Patients with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, corneal dystrophy or corneal degeneration, tear film deficiency, poor pupil dilation, etc.).
- •Patients with uncontrolled glaucoma or who require current treatment for glaucoma, or with visual field loss as a result of glaucoma.
- •Patients with retinal pathology or a history of retinal detachment.
- •Patients with proliferative diabetic retinopathy, macular degeneration, or other degenerative visual disorders.
- •Patients with a history of previous ocular surgery including corneal refractive surgery.
- •Patients with congenital bilateral cataracts.
- •Patients with marked microphthalmos or aniridia.
- •Patients who have only one functioning eye.
- •Patients who do not have the potential for visual acuity of 20/30 or better in each eye.
- •Patients lacking intact binocular vision.
- •Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract removal and lens implantation.
- •Patients who have incomplete or damaged zonules, or who have zonular rupture during cataract removal.
- •Patients with pupils greater than 7mm
结局指标
主要结局
Measuring Ocular Dominance
时间窗: 3 months
Overall post surgical outcomes
时间窗: 3 months
次要结局
- Measuring visual acuities(3 months)
研究者
研究点 (1)
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