NCT05069415已完成不适用
Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
研究概览
简要总结
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries.
- •Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
- •Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
排除标准
- •Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- •Clinically significant corneal dystrophy.
- •Irregular astigmatism.
- •History of chronic intraocular inflammation.
- •History of retinal detachment.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Previous intraocular surgery.
- •Previous refractive surgery.
- •Previous keratoplasty
- •Severe dry eye
- •Pupil abnormalities
- •Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
- •Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
结局指标
主要结局
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
时间窗: 3 months
次要结局
- Binocular Low Contrast Distance Visual Acuity at 3 Months(3 months)
- Distance-corrected Near Visual Acuity at Best Distance at 3 Months(3 months)
研究者
研究点 (4)
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