NCT02487160已完成3 期
Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Lenstec Incorporated26 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 499
- 试验地点
- 26
- 主要终点
- photopic, distance corrected, monocular intermediate visual acuity
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.
详细描述
The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 22 years of age, of any race and either gender
- •Operable, age related cataract grade in both eyes
- •Patients who require an intraocular lens (IOL) power in the range of 15 D - 30 D only
- •Able to comprehend and sign a statement of informed consent
- •Calculated lens power within the available supply range
- •Planned cataract removal by phacoemulsification
- •Potential postoperative visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes
- •In good general and ocular health
- •Patients with preoperative astigmatism ≤1.0 D Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
- •Clear intraocular media other than cataract in study eyes
- •Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
- •The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
- •Able to competently complete testing
- •Willing and able to attend study visits
排除标准
- •Previous intraocular surgery
- •Preoperative photopic pupil size of < 2.75 mm
- •Previous corneal refractive surgery
- •Any inflammation or edema (swelling) of the cornea
- •Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders ) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR
- •Subjects who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than neodymium-doped yttrium aluminium garnet (nd:YAG) capsulotomy)
- •Clinically significant ptosis
- •Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
- •Diabetic Retinopathy
- •Extremely shallow anterior chamber, not due to swollen cataract
- •Microphthalmia
- •Previous retinal detachment
- •Previous corneal transplant
- •Severe dry eye
- •Recurrent severe anterior or posterior segment inflammation of unknown etiology
- •Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the Investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)]
- •Rubella or traumatic cataract
- •Iris neovascularization
- •Glaucoma (medically controlled or uncontrolled)
- •Chronic severe uveitis
- •Optic nerve atrophy
- •Corneal decompensation
- •Greater than 1.0 D of astigmatism
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Pseudoexfoliation syndrome
- •Iris atrophy
- •Pupil abnormalities (e.g., corectopia)
- •Aniseikonia
- •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 Note: Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
- •Participation in another clinical trial within 30 days of study start
结局指标
主要结局
photopic, distance corrected, monocular intermediate visual acuity
时间窗: 1 year following implantation
a measure of intermediate vision
photopic, distance corrected, monocular near visual acuity
时间窗: 1 year following implantation
a measure of near vision
photopic, best corrected, monocular distance visual acuity
时间窗: 1 year following implantation
a measure of distance vision
presence or absence of adverse events
时间窗: 1 year following implantation
presence or absence of adverse events
次要结局
- Proportion of subjects who are independent of spectacles(1 year following implantation)
研究者
研究点 (26)
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