Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"

Heidelberg Engineering GmbH1 个研究点分布在 1 个国家目标入组 303 人2012年7月

适应症Glaucoma

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Glaucoma
发起方: Heidelberg Engineering GmbH
入组人数: 303
试验地点: 1
主要终点: Bruch's Membrane Opening - Minimum Rim Area, Global
状态: 已完成
最后更新: 9年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Collect OCT data to evaluate the range and age trend of ocular measurements.

详细描述

This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.

注册库

clinicaltrials.gov

开始日期

2012年7月

结束日期

2012年12月

最后更新

9年前

研究类型

Observational

性别

All

研究者

发起方

Heidelberg Engineering GmbH

责任方

Sponsor

入排标准

入选标准

•Subject is not an employee of the eye clinic.
•Age ≥18 to
•Able and willing to undergo the test procedures, give consent, and to follow instructions.
•Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
•Caucasian decent (self-reported).
•Negative history of glaucoma.
•Intraocular pressure ≤21mmHg.
•Best corrected visual acuity ≥0.
•Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
•Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.

排除标准

•Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
•Unusable disc stereo photos.
•Inability to undergo the tests.
•Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
•Retina completely included in image frame,
•Quality Score ≥ 20 in the stored ART mean images, and
•For ONH-R scan: Center position error ≤ 100 μm.
•Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.

结局指标

主要结局

Bruch's Membrane Opening - Minimum Rim Area, Global

时间窗: 3 months

Primary Endpoints

时间窗: 3 months

The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.