NCT03790592已完成不适用
Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Corrected distance visual acuity
研究概览
简要总结
Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients
详细描述
Compare preoperative and postoperative Corrected distance visual acuity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- •Patients of any gender, aged 18 years or older
- •Assured follow-up examinations
- •Post-operative astigmatism ≤ 0.75 Diopter
- •IOL implanted into the capsular bag with trifocal IOL in both eyes
- •Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes
- •Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR
- •Normal findings in the medical history and physical examination
排除标准
- •Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
- •Patients whose freedom is impaired by administrative or legal order
- •Concurrent participation in another drug or device investigation that affects patients vision
- •Signs of early cataract in either eye
- •Preoperative monocular and binocular CDVA worse than 0.2 logMAR
- •Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye
- •Cataract of any grade
- •Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, clinically significant anterior membrane dystrophies, poor pupil dilation, etc.)
- •Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- •Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
- •Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
- •Patient expected to require retinal laser treatment before 6 month follow-up visit
- •Patient require refractive laser treatment / refractive laser touch-up before 6 month follow up visit
- •Current Systemic or ocular pharmacotherapy that effects patients vision
- •Floppy iris syndrome
- •Monophthalmic patient
- •Previous corneal surgery
- •Previous use of cytotoxic drugs or total body irradiation
- •Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of mercury (mmHg) under ocular hypertension treatment
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
结局指标
主要结局
Corrected distance visual acuity
时间窗: 4 to 6 months postop
preoperative and postoperative Corrected distance visual acuity will be assessed
次要结局
未报告次要终点
研究者
研究点 (1)
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