A Multi-center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate the Safety and Effectiveness of the Full Visual Range AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 27
- 主要终点
- Primary Effectiveness Outcome
研究概览
简要总结
The goal of this clinical trial is to demonstrate the safety and effectiveness of the full visual range AT ELANA 841P IOL when used to treat adult patients having cataract surgery. Subjects will be randomly selected to receive a pair of IOLs, either the AT ELANA 841P or CT LUCIA 621P lens design. All patients will undergo surgery in both eyes, and they will receive follow up care for up to 6-months. During this time, all patients will undergo thorough eye exams at every study visit and complete questionnaires about their quality of vision post-surgery.
详细描述
The goal of this clinical trial is to demonstrate safety and effectiveness of the full visual range AT ELANA 841P posterior chamber IOL when used to treat adult patients undergoing cataract surgery. In this study, all patients will be randomly assigned (using a 1 to 1 ratio) to receive either the investigational device: AT ELANA 841P trifocal IOL, or the commercially available, FDA-approved, control device: CT LUCIA 621P monofocal IOL.
There will be 286 adults, 22 years of age or older. All will be scheduled to undergo cataract surgery in both eyes; along with completing a 6-months follow-up. This clinical trial will take place at 14 clinical sites located throughout the United States.
Salus IRB will provide ethical oversight for this clinical trial, while Ora, Inc. is the CRO assisting the research sites with completing all required study activities.
This clinical trial is expected to be about 18-months long.
Each participant who provides their consent for study participation must meet the following visual criteria to qualify:
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, Outcomes Assessor)
盲法说明
Masking will include not knowing which type of IOLs were received by the subject until end of the study.
入排标准
- 年龄范围
- 22 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 22 years of age or older at the time of study enrollment
- •Bilateral cataractous lens changes as demonstrated by best corrected distance visual acuity of 0.30 logMAR (20/40) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
- •Best corrected distance visual acuity projected to be better than 0.20 logMAR (better than 20/30) after cataract removal and IOL implantation
- •Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) in both operative eyes
- •Clear intraocular media other than cataract
- •Contact lens wear is to be discontinued two (2) weeks for soft contact lenses both daily and extended wear; and ≥ 30 days for rigid gas permeable lenses prior to preoperative biometry and keratometry testing.
- •Calculated lens power within the available range
- •Subject is willing to sign the IRB-approved informed consent form
- •Subject is willing, able and has sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits
排除标准
- •Presence of systemic disease that could increase the operative risk or confound the outcome, including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- •Ocular condition that may predispose for future complications, including but not limited to dry eye syndromes or symptoms, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), history of cystoid macular edema, macular degeneration as confirmed by clinical examination and adjunct testing (e.g., OCT, FA)
- •Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or edema; conditions including but not limited to active/inactive keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia
- •Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including corneal transplants, retinal detachment, glaucoma surgeries, refractive laser procedures including but not limited to LASIK, limbal relaxing incision, Small Incision Lenticule Extraction (SMILE) etc.
- •Use of or history of use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase subject risk (e.g., Tamsulosin Hydrochloride [Flomax] or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g., small pupil/floppy iris syndrome], antimetabolites, etc.)
- •Currently taking systemic steroids and/or planned on taking systemic steroids prior to operative visit and during the course of the investigation.
- •Subjects with diagnosed degenerative visual disorders, including but not limited to macular degeneration or other retinal disorders (such as diabetic retinopathy, diabetic macular edema, retinal detachment) that are predicted to confound outcomes or to cause future acuity loss to 0.20 logMAR or worse.
- •Subjects with conditions that increase the risk of zonular rupture (e.g., pseudoexfoliation syndrome, Marfan's syndrome) during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL
- •Expected concomitant ocular procedure during cataract surgery or within the next 12 months (e.g., glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty [PK], laser-assisted in situ keratomileusis, SMILE etc.)
- •Subjects who are expected to require retinal laser treatment within the next 12 months
- •History of amblyopia or monofixation syndrome with poor stereoscopic vision
- •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
- •Iris defects (e.g., aniridia)
- •Optic nerve atrophy
- •Keratoconus or Irregular astigmatism, as determined by topography
- •Inability to perform keratometry, topography or biometry (including but not limited to cataract density, subject unable to focus for longer time etc.) or subjects with unstable keratometry, topography or biometry measurements
- •Pathologic miosis caused by anterior segment pathology in the study eye (e.g., chronic uveitis, iritis, rubeosis iridis, neurological conditions such as multiple sclerosis, Argyle Robertson's pupil, acquired or congenital Horner´s syndrome, etc.)
- •Pupil diameter less than 6 mm when fully dilated
- •Pregnant, lactating at time of enrollment, or has another condition with associated fluctuation of hormones that could lead to refractive changes
- •Subject whose freedom is impaired by administrative or legal order
- •Concurrent participation in another drug or device investigation that could confound the outcome of this investigation
- •Subjects unable to achieve keratometry stability after discontinuing contact lens wear
- •Gonioscopic abnormalities
研究组 & 干预措施
AT ELANA 841P IOL
Cataract Surgery to implant multifocal intraocular lenses
干预措施: Cataract Surgery (Device)
CT LUCIA 621P IOL
Cataract Surgery to implant monofocal intraocular lenses
干预措施: Cataract Surgery (Device)
结局指标
主要结局
Primary Effectiveness Outcome
时间窗: Month 6
Mean, monocular photopic logMAR best-corrected distance visual acuity (BCDVA) at 4 m for the first implanted eyes, at Month 6 (Visit 4).
Primary Safety Outcome
时间窗: Month 6
Mean log monocular mesopic far contrast sensitivity (without glare at spatial frequency of 1,5, 3, 6, and 12 cycles/degree) for first implanted eyes in Best Case Set (BCS), at Month 6 (Visit 4)
次要结局
未报告次要终点