NCT07092020已完成不适用
A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 27
- 主要终点
- Mean monocular negative defocus range at the 0.20 logMAR compared to control
研究概览
简要总结
Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)
详细描述
Extended depth of Focus intraocular lens versus a monofocal 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
- Double (Participant, Investigator)
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
- •Patients of any gender, aged 18 years or older
- •Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement
- •Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
- •Calculated lens power within the available range
- •Clear intraocular media other than cataract
- •Patient is willing and capable of providing informed consent
- •Patient is willing and capable of complying with visits and procedures as defined by this protocol
排除标准
- •Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- •Endothelial cell count of less than 2000/mm2
- •Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- •Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study
- •Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia
- •Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.)
- •Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- •Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study
- •Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk
- •Clinically significant gonioscopic abnormalities
- •Amblyopia, strabismus, single eye status
- •Rubella, congenital, traumatic or complicated cataracts
- •History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
- •Microphthalmos or macrophthalmos
- •Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)
- •Pseudoexfoliation
- •Keratoconus or irregular astigmatism
- •Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)
- •Pathologic miosis
- •Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes
- •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 clinical investigation in the last 30 days.
研究组 & 干预措施
Extended depth of focus (EDF)
Experimental
Extended depth of focus
干预措施: EDF (Device)
Monofocal
Active Comparator
Monofocal
干预措施: Monofocal IOL (Device)
结局指标
主要结局
Mean monocular negative defocus range at the 0.20 logMAR compared to control
时间窗: 6 Months
Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
时间窗: 6 Months
Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m
时间窗: 6 Months
Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus)
时间窗: 6 Months
Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better
时间窗: 6 Months
次要结局
- Patient Reported Outcome (PRO)(6 Months)
研究者
研究点 (27)
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