NCT05418153已完成不适用
Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers
Center For Sight2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
研究概览
简要总结
This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years and older.
- •Gender: Males and Females.
- •Uneventful bilateral lens extraction
- •Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visit and study examination procedures.
- •At least 3 months postoperative from second eye IOL implantation.
- •Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
排除标准
- •Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- •Clinically significant corneal dystrophy.
- •Irregular astigmatism.
- •History of chronic intraocular inflammation.
- •Previous intraocular surgery.
- •Previous keratoplasty
- •Previous refractive surgery.
- •Severe dry eye
- •Pupil abnormalities
- •Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
- •Best-corrected distance visual acuity worse than 20/32 in each eye.
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Abnormal iris
- •Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
结局指标
主要结局
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
时间窗: Up to 1 year
Visual acuity measured at 40 cm under dim light
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
时间窗: Up to 1 year
Visual acuity measured at 40 cm
次要结局
未报告次要终点
研究者
研究点 (2)
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