跳至主要内容
临床试验/NCT05829980
NCT05829980尚未招募不适用

Contoura Topography-guided Ablation Versus Wavefront-optimized Ablation for Correction of Astigmatism

Hebatallah MT Abdelmoniem0 个研究点目标入组 128 人开始时间: 2023年6月最近更新:
适应症

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

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

发起方
Hebatallah MT Abdelmoniem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hebatallah MT Abdelmoniem

Assistant Lecturer

Assiut University

相似试验