Contoura Topography-guided Ablation Versus Wavefront-optimized Ablation for Correction of Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- Number of lines of preoperative CDVA compared to postoperative
研究概览
简要总结
To evaluate the efficacy, safety and accuracy of Contoura topography-guided LASIK & PRK in comparison to Wavefront optimized LASIK & PRK in virgin eyes with astigmatism.
详细描述
In Upper Egypt, The second principal cause of blindness was uncorrected refractive errors accounting for 16% of sample population. It was reported that astigmatism (defined as cylinder power > 0.5 D) was the most common refractive errors in children and adults followed by hyperopia and myopia.
Laser vision correction has been established over the last 2 decades as a safe and effective intervention to treat refractive errors, being one of the main techniques practiced globally.
However, many subjects after LASIK had uncorrected distance visual acuity (UDVA) greater than 1.0, they complain about poor night vision, glare, and double vision. As studies have shown that every 1° deviation of the astigmatic axis could result in loss of correction of 3.3%. Even residual astigmatism less than 0.50D could have an actual impact on visual quality.
Excimer laser ablation used in the correction of refracted errors especially astigmatism may reduce quality of vision, and that is attributed to the induced optical aberrations. The most prevalent of these optical aberrations is the spherical aberration.
Among multiple sophisticated profiles that developed to optimize visual outcomes, wavefront optimized profile which compensate for corneal curvature to reduce spherical aberration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Astigmatism (up to 5.0 diopters) or less.
- •Central corneal thickness (CCT) of 500 microns or more
- •Estimated Residual stromal bed thickness (RSB) of 280 microns or more
- •Subject has provided written informed consent
排除标准
- •Keratoconus
- •Abnormal topography
- •previous ocular trauma or eye surgery
- •pre-existing diseases of the vitreous, macula, or optic nerve that can affect visual outcome
- •patients with uveitis and anterior segment pathology
- •patients with corneal pathology or Severe dry eye
- •pregnancy or breast-feeding females
- •uncontrolled vascular or autoimmune disease
结局指标
主要结局
Number of lines of preoperative CDVA compared to postoperative
时间窗: 3 month
Change in lines of CDVA from baseline preoperative to 3 month postoperative (in LogMAR)
Amount of Residual Astigmatism postoperatively (in Diopters)
时间窗: 3 month
residual astigmatism 3 month postoperatively
Postoperative mean spherical equivalent MSE compared to Preoperative MSE (in Diopters)
时间窗: 3 month
changes in mean spherical equivalent baseline preoperative to 3 month postoperative
Change in Postoperative UDVA compared to preoperative CDVA (in LogMAR)
时间窗: 3 month
UCVA 3 month after surgery compared to baseline preoperative CDVA
次要结局
- Amount of High order aberrations(3 month)
- Change in Contrast sensitivity test(3 month)
研究者
Hebatallah MT Abdelmoniem
Assistant Lecturer
Assiut University
