NCT00366496已完成不适用
Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Contrast sensitivity
研究概览
简要总结
To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.
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
- Double
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral cataract
- •Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
- •Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
- •Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
- •Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.
排除标准
- •Preoperative ocular pathology potentially affecting visual acuity
- •Previous intraocular or corneal surgery.
- •Keratometric astigmatism exceeding 1.5 diopters.
- •Planned postoperative refraction for mono-vision.
- •Current contact lens usage.
- •Other ocular surgery at the time of the cataract extraction.
- •Uncontrolled diabetes.
- •Any neurological condition that might interfere with performance of required test.
- •Auto-immune deficiency disease.
- •Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Surgical Exclusion Criteria
- •Significant anterior chamber bleeding.
- •Detached Descemet's membrane
- •Iris damage
- •Posterior capsule rupture
- •Radial tear in capsulorhexis
- •Vitreous loss
- •Zonular rupture.
- •Use of corneal sutures for more than 1 week.
- •Post-implantation Exclusion Criteria
- •Haptic not in the capsular bag.
- •Descentration of the IOL of more than 1.0 mm
- •Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.
结局指标
主要结局
Contrast sensitivity
Visual acuity
次要结局
- Induction of hight order aberrations
- Corneal topography
- Patient satisfaction
研究者
相似试验
已完成
不适用
Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract SurgeryPresbyopiaCataractNCT02595177Federal University of São Paulo30
已完成
不适用
EDOF and Multifocal IOL StudyAge-related CataractNCT05573529Medical University of Vienna50
已完成
不适用
A Randomised Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLsPresbyopiaCataractNCT03117426Maastricht University Medical Center30
Unknown
不适用
Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of PresbyopiaPresbyopiaCataract SenileNCT04265846Peking University Third Hospital140
已完成
不适用
Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension RingCataractNCT02183831Yonsei University52