NCT07790185招募中4 期
Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Establish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units
研究概览
简要总结
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ages 18 to 45 years old.
- •Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery or stability as determined by the investigator.
- •Myopia with or without astigmatism and MRSE within the range of indications for wavelight plus (myopia up to -8.00D, astigmatism up to -3.00D, S.E. more than -1.00 and up to -9.00D)
- •Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
- •Subjects who have elected to undergo bilateral LASIK targeted for emmetropia.
- •Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
- •Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Mesopic pupil size ≥4.5mm
- •Less than 0.75D spherical equivalent differences between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
- •Subjects who regularly drive at night and expect to continue night driving throughout the duration of the study, as determined by investigator assessment
排除标准
- •Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or have another condition with associated fluctuation of hormones that could lead to refractive changes.
- •Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
- •Previous corneal ocular surgery
- •History of evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma or glaucoma suspect.
- •Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
- •Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator.
- •Subjects who, in the judgment of the Investigator, present any emotional, physiological, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- •Patients with a calculated residual stromal depth <250 um
结局指标
主要结局
Establish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units
时间窗: Baseline compared to 6 month post operative visit
Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)
时间窗: Baseline compared to 6 month post operative visit
次要结局
- Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op(Baseline compared to 6 month post operative visit)
- Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+(Baseline compared to 6 month post operative visit)
- Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op(Baseline compared to 6 month post operative visit)
- Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op(Baseline compared to 6 month post operative visit)
- Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op(Baseline compared to 6 month post operative visit)
- Refractive predictability, percentage of eyes within ±0.25D, ±0.50D of target MRSE at 6-month post-op(Baseline compared to 6 month post operative visit)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Wavelight plus LASIK 术后视觉结果和患者满意度的评估：双向性，观察性，多中心研究屈光不正ChiCTR2500107271爱尔康视力有限责任公司224
已完成
不适用
A study to assess Visual Acuity, vision related Quality of Life (QoL) among diabetic retinopathy patients.CTRI/2025/05/087010All India Institute of Medical Sciences New Delhi200
尚未招募
不适用
Partial Range Of Field IOLs in DMEK-Enabled ProceduresCataractNCT07441616Universitair Ziekenhuis Brussel10
尚未招募
不适用
Visual Outcomes and Satisfaction comaprison in patients undergoing Intraocular lens implantation via Phacoemulsification.CTRI/2024/04/065438Aravind Eye Hospital Chennai141
尚未招募
Phase 3 4
Safety and Efficacy of a New Enhanced Monofocal Intraocular LensMedical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract,CTRI/2024/05/067844Nethradhama Super Speciality Eye Hospital60