Post-Market Evaluation of Topography-Guided Treatment with the MEL Excimer Laser in Normal Virgin Eyes.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Visual acuities,
研究概览
简要总结
The clinical trial is a Post-Market Evaluation of Topography-Guided Treatment with the MEL Excimer Laser in Normal Virgin Eyes. Up to 75 subjects will be enrolled to achieve 60 bilaterally treated subjects 3-months postoperatively. A minimum of 10 subjects and no more than 50% of all subjects are to be enrolled at each site.
Subjects will be screened according to the following assessments at the preoperative visit: visual acuity testing, manifest refraction, corneal topography, slit-lamp examination, intraocular pressure (IOP), pupil diameter (mesopic), dilated fundus examination, keratometry, pachymetry, wavefront aberrometry, contrast sensitivity, and patient questionnaire. Subjects meeting all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. Subjects who provide written informed consent to participate in the study will be undergo topography-guided customized ablations (centered on the corneal vertex) using the CRS-Master and MEL80/90 excimer laser.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female subjects of age between 18 to 40 years old
- •Scheduled to undergo bilateral LASIK surgery for myopia or myopic astigmatism
- •Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
- •Normal corneal topography in each eye
- •Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination
- •Preoperative corneal astigmatism less than or equal to 2 D in each eye
- •Corneal astigmatism and refractive cylinder are with 0.50 D and axis within 10°
- •Preoperative corneal higher order aberrations (HOA) RMS less than or equal to 0.4 microns in each eye
- •Preoperative whole eye higher order aberrations (HOA RMS less than or equal to 0.5 microns measured at a 6 mm pupil diameter in each eye
- •Angle kappa less than or equal to 5 degrees in each eye
- •Residual stromal thickness greater than or equal to 280 microns in each eye
- •Availability, willingness, to comply with examination follow up visits
- •Signed informed consent and data protection documents.
排除标准
- •Irregular corneal astigmatism in each eye
- •Ocular surface disease in each eye
- •History of ocular surgery, ocular pathology, or other significant ocular findings that, in the investigator’s opinion, may increase the patient’s risk for corneal refractive surgery or affect potential visual outcomes in each eye
- •Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
- •Amblyopia, strabismus, nystagmus, forme fruste keratoconus in each eye
- •Clinically significant pupil abnormalities in each eye
- •Desire for monovision correction
- •Use of systemic or ocular medications that may affect visual outcomes
- •Systemic pathology that may affect the results of the study
- •Pregnancy or being treated for conditions associated with hormonal fluctuations
- •Participation in another clinical trial in the last 30 days.
结局指标
主要结局
Visual acuities,
时间窗: Preoperative, Operative, 1-day, 1-Month, and 3‑Months postoperative.
Refractive outcomes,
时间窗: Preoperative, Operative, 1-day, 1-Month, and 3‑Months postoperative.
Corneal high-order aberrations,
时间窗: Preoperative, Operative, 1-day, 1-Month, and 3‑Months postoperative.
Patient questionnaire.
时间窗: Preoperative, Operative, 1-day, 1-Month, and 3‑Months postoperative.
次要结局
- NA(NIL)
研究者
Dr Sandeep Singh
CBCC Global Research LLP