A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- best spectacle corrected distant visual acuity
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.
详细描述
This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking.
Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2.
All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism
- •age > 18 years
- •provided written informed consent
- •difference between the MRSE and cycloplegic SE less than 0.75 D
- •MRSE needed to be stable for the last 12 months (<0.5 D).
排除标准
- •prior corneal surgery,
- •forme fruste or manifest keratoconus,
- •history of corneal scarring, melting, ulceration
- •repeating inflammations of the eye
- •taking vitamin C 1 week prior to the treatment
研究组 & 干预措施
Study group
LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.
干预措施: LasikXtra (Procedure)
Control group
LASIK only
干预措施: LASIK (Procedure)
结局指标
主要结局
best spectacle corrected distant visual acuity
时间窗: 12 months postoperative
best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
uncorrected distant visual acuity
时间窗: 12 months postoperative
uncorrected distant visual acuity (logarithmic minimum angle of resolution)
spherical equivalent
时间窗: 12 months postoperative
spherical equivalent (diopter)
次要结局
- Corneal thickness(12 months postoperative)
- endothelial cell count(12 months postoperative)
- Subjective visual quality(12 months postoperative)
研究者
Professor Dr. med. Thomas Kohnen
Head of Ophthalmology, Principal Investigator, Clinical Professor
University Clinic Frankfurt