Topography-Guided Customized PRK (Photorefractive Keratectomy) Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- change in Q value
研究概览
简要总结
This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures:
topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II).
Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation.
The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.
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
- •Age more than 18 years
- •Myopia with up to -6.5 D with or without astigmatism up to -4.75 D
排除标准
- •anterior segment abnormalities (ie, cataracts, corneal scarring)
- •basement membrane disease
- •history of recurrent corneal erosions
- •Schirmer's test less than 5 mm
- •established or forme fruste keratoconus
- •macular or retinal disease
- •current use of immunosuppressive therapy
- •autoimmune disease
- •pregnancy, and lactation
结局指标
主要结局
change in Q value
时间窗: 1,3 and 6 months
assessed by topolyzer
change in strehl ratio
时间窗: 1,3 and 6 months
by CSO scheimpflug
change in corneal wavefront aberrations
时间窗: 1 , 3 and 6 months postoperative
assessed by topolyzer
change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer
时间窗: 1 , 3 and 6 months postoperative
change in visual acuity using snellen chart
时间窗: 1 , 3 and 6 months postoperative
change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug
时间窗: 1,3 and 6months
by CSO Sirius scheimpflug
change in total RMS
时间窗: 1,3 and 6months
by CSO Sirius scheimpflug
次要结局
- stability(6 months)
- efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA(6 months)
- contrast sensitivity(6 months)
- predictability(6 months)
- safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA(6 months)
研究者
Rania Elsayed Gad
Assisstant lecturer Faculty of Medicine Helwan University
Kasr El Aini Hospital