Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Effective Lens Position
研究概览
简要总结
The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.
详细描述
The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=40 years of age, of any race and either gender
- •Operable, age related cataract grade 3+ or lower in the study eye
- •Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
- •≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
- •Able to achieve a dilated pupil >6.0 millimeter (mm) in the study eye
- •Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
- •Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
- •In good general and ocular health
- •Able to competently complete testing
- •Willing and able to attend study visits
- •Willing and able to understand and sign an informed consent
排除标准
- •Previous intraocular surgery or laser treatment
- •Severe dry eye
- •Uncontrolled IOP or glaucoma
- •Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
- •History of retinal detachment
- •Microphthalmia
- •Chronic severe uveitis
- •Corneal decompensation
- •Irregular astigmatism
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- •Pseudoexfoliation syndrome
- •Iris atrophy
- •Pupil abnormalities (e.g., corectopia)
- •Aniseikonia
- •Amblyopia
- •An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- •Pregnant, lactating, or planning to become pregnant during the course of the trial
- •Participation in another clinical trial within 30 days of study start
结局指标
主要结局
Effective Lens Position
时间窗: 6 Months Postoperative
The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.
次要结局
未报告次要终点