Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 主要终点
- Percentage of Participants Classified as Responders
研究概览
简要总结
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
详细描述
This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and sign an Informed Consent;
- •Willing and able to attend post-operative examinations as per protocol schedule;
- •Diagnosis of bilateral, age-related cataracts;
- •Planned cataract removal via phacoemulsification with implantation of an IOL;
- •Available to undergo second eye surgery within 6 weeks of the first eye surgery;
- •Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
- •No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
- •Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
- •Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous corneal surgery and/or reshaping;
- •Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
- •Pregnant, lactating, or planning pregnancy during the course of study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL (Device)
ReSTOR +3 Toric
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL (Device)
ReSTOR +3 Toric
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL (Device)
Monofocal
Monofocal IOL, bilateral implantation
干预措施: Monofocal IOL (Device)
结局指标
主要结局
Percentage of Participants Classified as Responders
时间窗: Month 6 after second eye implantation
Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
时间窗: Month 6 after second eye implantation
Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.
Proportion of Participants Reporting Spectacle Independence at All Distances
时间窗: Month 6 after second eye implantation
Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.
次要结局
- Median Total Spectacle Cost Prior to Any Reimbursement(Month 6 after second eye implantation)