MULTICENTER, DOUBLE-ARM, PATIENT AND ASSESSOR-MASKED, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL TO COMPARE VISUAL PERFORMANCE OF NEGATIVE AND NEUTRAL ASPHERIC MONOFOCAL INTRAOCULAR LENSES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to compare the binocular distance, intermediate, and near visual acuity and patient reported outcomes of the Johnson &Johnson Eyhance and Bausch & Lomb enVista IOLs.
We hypothesize that the Johnson & Johnson's Eyhance and Bausch & Lomb enVista IOLs will have similar distance, intermediate, and near visual acuity.
详细描述
This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery with one of two intraocular lenses: Johnson & Johnson Eyhance or Bausch & Lomb enVista. Note that neither of these lenses are considered investigational devices; both lenses are FDA approved in the United States for implantation during cataract surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 or older at the time of study enrollment.
- •Visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
- •Projected postoperative CDVA 0.20 logMAR (Snellen 20/32) or better in the study eye, as determined by an Investigator's medical judgement.
- •Calculated spherical power targeted at emmetropia at distance in the study eyes.
- •Calculated IOL power between +5.0 - +34.0 D, inclusive, in both eyes.
- •Measured keratometric astigmatism less than 1.0 D if against-the-rule or 1.5 D if with-the-rule/oblique.
- •If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 21 days prior to preoperative biometry.
- •Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
- •Willingness to sign the IRB-approved informed consent form (ICF) for study participation.
排除标准
- •Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
- •Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.
- •Abnormal corneal findings in the study eye (e.g. keratoconus, pellucid marginal degeneration, irregular astigmatism).
- •Any anterior segment pathology in the study eye that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, clinically significant corneal dystrophies, etc.)
- •Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
- •History of severe dry eye in the study eye that, in the judgement of the investigator, would impair the ability to obtain reliable study measurements.
- •History of serious corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.) in the study eye.
- •History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit final post-operative visual prognosis (e.g. diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).
- •History of cystoid macular edema in either eye.
- •History of uveitis in either eye.
- •History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), selective laser trabeculoplasty (SLT), or argon laser trabeculoplasty (ALT).
- •Uncontrolled glaucoma in the study eye (per Investigator judgement).
- •Current ocular infection in the study eye.
- •Presence of uncontrolled systemic disease that could increase operative risk (e.g. diabetes mellitus, mental illness, dementia, clinically significant atopic disease, etc.).
- •Planned concomitant ocular procedure during cataract surgery inclusive of glaucoma surgery e.g. MIGS or limbal relaxing incisions.
- •Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement.
研究组 & 干预措施
Johnson & Johnson Eyhance
This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery
干预措施: Negative Aspheric Monofocal IOL (Device)
Bausch & Lomb enVista.
This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery
干预措施: Neutral Aspheric Monofocal IOL (Device)
结局指标
主要结局
Visual acuity
时间窗: 1 month post cataract surgery
Mean logMAR best-distance corrected visual acuity at intermediate (66 cm) tested in binocular photopic conditions at 1 month (binocular DCIVA).
次要结局
未报告次要终点
研究者
Seth M Pantanelli
Professor, Department of Ophthalmology
Milton S. Hershey Medical Center