NCT07260695招募中4 期
Study Evaluating Visual Outcomes in Post-Myopic LASIK Patients After Implantation of the Odyssey Intraocular Lens
Center For Sight2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Binocular defocus curve
研究概览
简要总结
This prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the IOL's performance in terms of distance, intermediate, and near vision, and patient satisfaction. Its design features may offer favorable outcomes in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- •Age: 50 years and older.
- •Gender: Males and Females.
- •Bilateral cataracts
- •Bilateral implantation of Odyssey IOLs (toric and non-toric)
- •Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries.
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and study examination procedures.
- •Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye.
排除标准
- •Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- •Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/25) 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.
- •Contact lens use during the active treatment portion of the trial.
- •Irregular astigmatism.
- •Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities
- •History of chronic intraocular inflammation.
- •History of retinal detachment.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Previous intraocular surgery.
- •Previous keratoplasty
- •Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc)
- •Severe dry eye.
- •Pupil abnormalities.
- •Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK).
- •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.
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Abnormal iris
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
结局指标
主要结局
Binocular defocus curve
时间窗: 3 months postoperatively
The defocus curve assesses a patient's visual performance at various distances by introducing different levels of lens defocus (measured in diopters) and recording the corresponding visual acuity. It provides a comprehensive evaluation of the range of clear vision (distance, intermediate, and near) offered by an intraocular lens.
次要结局
- Patient satisfaction(3 months postoperatively)
- Spectacle independence at near.(3 months postoperatively)
研究者
研究点 (2)
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