NCT01192321终止4 期
Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Uncorrected Distance Visual Acuity
研究概览
简要总结
The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are willing and able to understand and sign an informed consent;
- •are willing and able to attend postoperative examinations per protocol schedule;
- •are ≥ 21 years of age, of either gender and any race;
- •have bilateral, age related, cataracts;
- •have planned cataract removal via phacoemulsification with implantation of an intraocular lens (IOL);
- •are available to undergo second eye surgery within 6 weeks of the first eye surgery;
- •are in good ocular health, with the exception of cataracts;
- •are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies.
- •have regular corneal astigmatism;
- •qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator (www.acrysoftoriccalculator.com)
- •are able to obtain pupil dilation ≥ 5.0 mm
- •are able to read and understand one of the following languages: Dutch, French, German
排除标准
- •previous corneal surgery and/or reshaping
- •abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens
- •planned multiple procedures during cataract/IOL implantation surgery
- •planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study
- •an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.)
- •pregnant, lactating or planning pregnancy during course of study. Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.
结局指标
主要结局
Uncorrected Distance Visual Acuity
时间窗: 6 Months After Surgery
Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Spectacle Independence
时间窗: 6 Months After Surgery
Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.
次要结局
- Vision-related Quality of Life(6 Months After Surgery)
研究者
研究点 (2)
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