NCT00760487已完成4 期
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 a candidate for bilateral implantation
- •In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
- •In need of spherical correction between 10.0 Diopter (D) and 30.0 D
- •Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
- •Willing and able to complete all required postoperative visits
- •Able to comprehend and sign a statement of informed consent
- •Pupil dilation ≥ 6.0 mm
- •Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);
排除标准
- •Exclusion Criteria Before Surgery - Ocular
- •Previous cataract patient without potential of bilateral implantation
- •Females of child bearing potential
- •Irregular corneal astigmatism
- •Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
- •Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
- •Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
- •Clinically significant corneal dystrophy (including Fuch's dystrophy)
- •Previous corneal transplant
- •Amblyopia
- •Glaucoma (medically uncontrolled)
- •Clinically significant RPE/Macular changes
- •Proliferative diabetic retinopathy
- •History of macular edema
- •Previous history of retinal detachment
- •History of uveitis/iritis
- •Extremely shallow anterior chamber, not due to swollen cataract
- •Iris neovascularization
- •Microphthalmos
- •Absent eye or eye with no light perception (NLP) as fellow eye
- •Rubella, congenital, traumatic, or complicated cataract
- •Optic atrophy
- •Exclusion Criteria During Surgery
- •Other procedures at this surgery
- •Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study
结局指标
主要结局
Visual Acuity (VA)
时间窗: Pre-operative, 1 month, 3 month, and 6 month post-operative
Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
次要结局
- Spectacle Independence(6 months post-operative)
- IOL Rotation(6 months post-operative)
研究者
研究点 (2)
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