NCT03839420已完成不适用
Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- IOL axis
研究概览
简要总结
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
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
- 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 Clinical Investigational Plan and who has given his/her written informed consent
- •Patients of any gender, aged 18 or older
- •Assured follow-up examinations
- •Healthy eyes with clinically significant age related cataract requiring surgical treatment
- •Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
- •Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
- •Cataract density compatible with biometry measurement
排除标准
- •Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
- •Patients whose freedom is impaired by administrative or legal order
- •Current participation in another drug or device investigation that affects patients vision
- •Ocular disorders, other than cataract, that could potentially cause future acuity loss
- •Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, 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, Floppy iris syndrome etc.)
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
- •Pseudoexfoliation syndrome (according to investigator decision)
- •Pathologic miosis or Pharmacotherapy with miotic agent
- •Irregular astigmatism / Keratoconus
- •Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
- •All kind of infections (acute ocular disease, external / internal infection, systemic infection)
- •Traumatic cataract
- •Monophthalmic patient
- •Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
- •Patient expected to require retinal laser treatment before the end of the last follow-up examination
- •Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
- •Previous intraocular and corneal / refractive surgery
- •Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
- •Previous use of cytotoxic drugs or total body irradiation within last 2 years
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- •Pregnancy and / or lactation period
结局指标
主要结局
IOL axis
时间窗: Immediately after the surgery
IOL axis will be analyzed based on images.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and ManufacturingCataractNCT01249144Lenstec Incorporated75
Unknown
不适用
SEED-LVPEI Myopia StudyMyopiaNCT04618510L.V. Prasad Eye Institute108
已完成
不适用
Patients Outcomes of a Monofocal Intraocular Lens Designed for MonovisionCataractNCT06528678Clinica Baviera51
已完成
不适用
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)AphakiaNCT04098367Alcon Research222
进行中（未招募）
不适用
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia ControlMyopia, ProgressiveNCT05894382Shanghai Eye Disease Prevention and Treatment Center236