A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 46
- 主要终点
- Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
研究概览
简要总结
The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
详细描述
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
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
The Investigator implanting the IOL and designated site personnel will be unmasked to the assignment of IOLs. Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- •Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
- •Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
- •Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.
- •Subjects must have clear intraocular media other than the cataract in both eyes.
- •Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear.
- •Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
- •Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.
排除标准
- •Subjects who have used an investigational drug or device within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
- •Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye.
- •Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
- •Subjects who have uncontrolled glaucoma in either eye.
- •Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
- •Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
- •Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
- •Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the study (refer to the relevant attachment of the Study Reference Manual).
- •Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
- •Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/100 or worse in either eye.
- •Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
- •Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
- •Subjects who have a preoperative corneal astigmatism > 1.0 D in either eye, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
- •Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
- •Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
- •Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Investigator.
- •Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study.
- •Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study.
- •Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura).
结局指标
主要结局
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
时间窗: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
时间窗: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
时间窗: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation
Serious Adverse Events
时间窗: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
时间窗: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
时间窗: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes
次要结局
- Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4(Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.)
- Photopic Binocular UNVA at 40 cm at Postoperative Visit 4(Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.)
- Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4(Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.)
- Photopic Binocular UIVA at 66 cm at Postoperative Visit 4(Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.)
- First-eye BCDVA Evaluated at Postoperative Visit 5(Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline)
- First-eye DCNVA Evaluated at Postoperative Visit 5(Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline)
- First-eye DCIVA Evaluated at Postoperative Visit 5(Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline)