Treatment of Keratoconus With Advanced Corneal Crosslinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Change from baseline in refraction
研究概览
简要总结
The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
详细描述
The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects.
At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the 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
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients planned for corneal crosslinking.
- •Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry.
- •A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
- •Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal.
- •18-28 years of age
- •No ocular abnormalities except keratoconus
- •No previous ocular surgery
- •No cognitive insufficiency interfering with the informed consent.
排除标准
- •Age under 18 or over 28
- •Any corneal abnormalities except keratoconus
- •Previous ocular surgery
- •Cognitive insufficiency.
结局指标
主要结局
Change from baseline in refraction
时间窗: 1, 6, 24 and 60 months after the treatment
Refractive errors, including lower and higher order aberrations in the cornea
次要结局
- Change from baseline in corneal biomechanical stability measured with ORA(1, 6, 24 and 60 months after the treatment)
- Change from baseline in corneal biomechanical stability measured with ART(1, 6, 24 and 60 months after the treatment)
- Change from baseline in corneal biomechanical stability measured with GAT(1, 6, 24 and 60 months after the treatment)
- Change from baseline in ETDRS LogMAR visual acuity(1, 6, 24 and 60 months after the treatment)
- Change from baseline in corneal densitometry(1, 6, 24 and 60 months after the treatment)