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临床试验/NCT01432834
NCT01432834已完成不适用

Evaluation of the Efficacy of the Allegretto Wave and the Wavefront Optimized Ablation Profile in Non-anterior Astigmatisms

Democritus University of Thrace2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
vector analysis of astigmatism correction, following laser in-situ keratomileusis (LASIK) & photorefractive keratectomy (PRK) treatments.

研究概览

简要总结

The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).

详细描述

Different optical components of the eye contribute to the total astigmatism error.In specific, the anterior corneal surface is responsible for the anterior component of astigmatism fault (anterior astigmatism), while the posterior corneal surface and the lens are responsible for the posterior one (posterior astigmatism).

Regarding our study, 74 refractive surgery candidates were recruited. Only one eye from each candidate was randomly enrolled in the study. Of them, 40 eyes underwent LASIK treatment (LG group), while 34 eyes underwent PRK treatment (PG group). The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for the ablation in all groups. Preoperatively, the ocular residual astigmatism (ORA) was calculated for each eye, according to which each astigmatism fault was characterized as primarily anterior or non-anterior.ORA is the vectorial value of astigmatism arising from non-anterior sources. Its amount on total astigmatism (R) is determined by the magnitude ratio ORA/R. Ratios below 1 indicate primarily anterior astigmatism, while ratios above 1 indicate primarily non-anterior astigmatism. 20 LG eyes and 16 PG eyes presented primarily anterior astigmatism (LG-A and PG-A subgroups, respectively), while 20 LG eyes and 18 PG eyes demonstrated primarily non-anterior astigmatism (LG-NA and PG-NA subgroups, respectively). Postoperatively, vector analysis of astigmatism correction was conducted; The following indexes were calculated: a) Correction index (CI), b) Difference vector (DV) and c) Index of Success (IOS).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • astigmatism fault

排除标准

  • previous incisional eye surgery
  • evidence of any type of corneal pathology
  • evidence of any type of optic neuropathy
  • history of optic neuropathy
  • diabetes mellitus

结局指标

主要结局

vector analysis of astigmatism correction, following laser in-situ keratomileusis (LASIK) & photorefractive keratectomy (PRK) treatments.

时间窗: 6 months postoperatively

Vector analysis of astigmatism correction was conducted using preoperative and 6-month postoperative data. The following indexes were calculated: a) Correction index (CI) which is determined by the ratio of the surgically induced astigmatism (SIA) to the target induced astigmatism (TIA), b) Difference vector (DV) as an absolute measure of success, and, c) Index of Success (IOS) which is determined by the relationship of the DV to the TIA, as a relative measure of success.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Labiris

Senior Lecturer of Ophthalmology

Democritus University of Thrace

研究点 (2)

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