Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Corneal haze assessed with the the software analysing the corneal OCT images
研究概览
简要总结
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.
This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.
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
- Single (Participant)
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
- •Planned Photorefractive Keratectomy in both eyes
- •Simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50 and -9.0 diopters in both eyes with regular corneal topography
排除标准
- •Only one eye operated on
- •At least one contraindication to refractive surgery, namely : keratoconus, minimum corneal thickness < 400 µm, severe dry syndrome, progressive corneal infection
- •Personal history of corneal surgery
- •Personal history of ocular pathology other than simple myopia or myopic astigmatism
- •Pregnant or breastfeeding woman
结局指标
主要结局
Corneal haze assessed with the the software analysing the corneal OCT images
时间窗: 1 month after refractive surgery
Corneal haze assessed by the intensity of the luminosity of the whole cornea (expressed as a percentage) evaluated by the software analysing the corneal OCT images.
次要结局
未报告次要终点
