Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Uncorrected distant visual acuity (UDVA)
研究概览
简要总结
Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).
详细描述
Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK).
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.
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 (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
- •Candidates for Laser vision correction (LVC) with
- •Myopia up to -6 diopters
- •Myopic astigmatism up to -4 diopters
- •Corneal thinnest location ≥ 500 um and a residual stromal bed ≥ 300um.
- •Exclusion criteria
- •Patients not candidates for LVC.
- •Hyperopic patients.
- •Systemic disease that contraindicates LVC.
- •Intra- or post-operative complications.
排除标准
- 未提供
结局指标
主要结局
Uncorrected distant visual acuity (UDVA)
时间窗: 6 months
Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Postoperative Refraction (Spherical equivalent)
时间窗: 6 months
Measured by Topcon Auto-Keratorefractometer
次要结局
- Postoperative Haze(3 months)
- Epithelial healing duration(2 weeks)
- Postoperative pain(1 week)
研究者
Mahmoud Abdel-Radi
Principal Investigator
Assiut University