NCT06997003招募中不适用
Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Bausch & Lomb GmbH2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年6月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
研究概览
简要总结
Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).
- •Minimum 18 years of age.
- •Have read, understood, and signed an informed consent form (ICF).
- •Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.
- •Have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at preoperative visit for both eyes.
- •Study group 1 only: Have hyperopic refractive error with or without astigmatism; sphere between 0.00 D and 4.00 D, cylinder between 0.00 D and 3.00 D for both eyes; with a spherical equivalent (SE) between 0.50 D and 5.50 D for both eyes.
- •Study groups 2 and 3 only: Have myopic refractive error with or without astigmatism; sphere between -8.00 D and 0.00 D, cylinder between 0.00 D and -4.00 D for both eyes; with a spherical equivalent (SE) between -10.00 D and -1.00 D for both eyes.
- •Have CDVA of 20/25 (logMAR 0.1) or better in both eyes
- •Have normal corneal topography as determined by the Investigator for both eyes.
- •Have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination, and through the day of surgery.
- •All contact lens wearers must demonstrate a stable refraction (within ± 0.50 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in both eyes and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refraction for both eyes.
- •Have the ability to lie flat without difficulty.
- •Are willing and able to comply with the schedule for all post-surgery follow-up visits.
排除标准
- •Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns residual stroma thickness in any eye.
- •Tear Break-Up time (TBUT) <8 s in any eye.
- •Mesopic pupil size larger than the optical zone of the planned treatment for any eye.
- •History or evidence of active or inactive of corneal disease or infection in either eye (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.).
- •Central corneal scars affecting visual acuity or unstable keratometry with irregular mires in any eye.
- •Irregular astigmatism in any eye.
- •Keratoconus or suspicion of keratoconus (sub-clinical, forme fruste), corneal dystrophy in any eye.
- •Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject.
- •Ocular muscle disorder including a strabismus or nystagmus, or other disorder affecting fixation in any eye.
- •Evidence of retinal vascular disease in any eye.
- •History or evidence glaucoma or glaucoma suspect in any eye.
- •Acute or chronic disease or illness that would increase the operative risk, likely affect the wound healing or confound the outcomes of the study (e.g. immuno-compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.).
- •Use chronic systemic medications that may confound the outcome of the study or increase the risk to the subject, including, but not limited to steroids, antimetabolites, etc.;
- •Take medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
- •Known sensitivity to medications used for standard LASIK treatment.
- •Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study.
- •Concurrent or previous (within 30 days) participation in another drug or device investigation.
结局指标
主要结局
Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
时间窗: Assessed for approximately 90 days
Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better
时间窗: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D
时间窗: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D
时间窗: Assessed for approximately 90 days
次要结局
- Preservation of Corrected Distance Visual Acuity (CDVA)(Assessed for approximately 90 days)
- Induced Manifest Refraction Astigmatism(Assessed for approximately 90 days)
- Incidence of Adverse Events(Assessed from 0-90 days)
研究者
研究点 (2)
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