跳至主要内容
临床试验/NCT03288116
NCT03288116已完成不适用

Literature in Mansoura Ophthalmic Center ,Mansoura University

Dar Al Shifa Hospital0 个研究点目标入组 48 人开始时间: 2014年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
keratometric power of the corneal surface

研究概览

简要总结

patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)

详细描述

This cross-sectional study was carried out on patients presenting keratoconus in one eye and forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by the institutional research board of the Mansoura faculty of medicine and was performed in accordance with the ethical standards of the Declaration of Helsinki. All patients included in the study provided informed consent.

Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry (K)>47diopters or an inferior-superior (I-S) value >1.4diopters according to the Rabinowitz and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme fruste keratoconus was diagnosed if all the following criteria were found: 1) normal topography, 2) mean K<47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow eye.

The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes were included in (Group B).Control cases(Group C) were selected from the normal database of candidates for refractive surgery with the following:1)normal topography, 2)negative rotating Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was included in the study depending on a computer-based randomizing program).

The exclusion criteria included previous ocular surgery or trauma, significant corneal scarring or associated ocular pathology.

All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug corneal tomography examination, the patient was properly positioned on the chin rest and forehead strap. The patient was asked to blink several times then open both eyes and stare at a fixed target. After obtaining proper alignment, the automatic release mode started the scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three consecutive scans were taken of each eye by the same examiner. The average of the results of three acceptable measurements was included in the study. Each eye was required to have a corneal map with at least 9 mm of corneal coverage and no extrapolated data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
14 Years 至 44 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with clinically evident keratoconus in one eye and apparently normal in the fellow eye

排除标准

  • previous ocular surgery or truama,significant corneal scarring or associatedocular pathology

结局指标

主要结局

keratometric power of the corneal surface

时间窗: 1 year

in diopter

corneal thickness(pachymetry)

时间窗: 1 year

in micrometer

corneal elevations

时间窗: 1 year

in micrometer

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

magda torky

clinical professor

Dar Al Shifa Hospital

相似试验