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临床试验/NCT02388360
NCT02388360已完成4 期

The Impact of Topical Prostaglandin Analogs on the Biomechanical Properties of the Cornea in Patients With Open Angle Glaucoma

Maisonneuve-Rosemont Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
35
试验地点
1
主要终点
The Corneal Hysteresis (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)

研究概览

简要总结

The purpose of this study is to determine the influence of topical prostaglandin analog (PGA) medication on corneal biomechanical properties in patients undergoing PGA treatment for open-angle glaucoma.

详细描述

Patients: Thirty five patients (seventy eyes) with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes were recruited from the Montreal Glaucoma Institute, Montreal, QC, Canada. Informed consent was acquired from all participants. The research protocol of this study adhered to the tenets of the Declaration of Helsinki. It was approved by the Maisonneuve-Rosemont Hospital Ethics committee (Montreal, QC, Canada) and all patients signed a research consent form.

Study Procedures: Consenting patients undergoing topical PGA treatment in both eyes were asked to discontinue the PGA in their best eye and to continue the administration of PGA in the contralateral eye. All measurements were taken before PGA cessation (Visit 1) and repeated 6 weeks after cessation (Visit 2). Patients then restarted the application of PGA to the experimental eye and all measurements were repeated once more after an additional 6 weeks (Visit 3).

The best eye was selected based on less glaucoma damages. It was defined by the results of the Humphrey Visual Field (HFA, Carl Zeiss Meditec, Inc., Dublin, CA), Heidelberg Retinal Tomograph (HRT II, Heidelberg Engineering GmbH, Heidelberg, Germany) and Optical Coherence Tomography (CIRRUS HD-OCT, Carl Zeiss Meditec, Inc., Dublin, CA). The Humphrey Visual Field defines early glaucoma as a mean defect (MD) of -2.00 to -6.00 db, moderate glaucoma as a MD of -6.10 to -12.0 db and advanced as a MD less than -12.0 db. The Optical Coherence Tomography enables the identification of the better linear Cup/Disk ratio, Rim area, RNFL thickness and ganglion cells analysis between both of the patient's eyes. The lesser of the maximum IOP values recorded in each of the patient's eyes also contributed to the selection of the best eye.

Instruments: The Ocular Response Analyzer (ORA) (Reichert, INC, Depew, NY) was used to assess the biomechanical properties of the cornea. This instrument utilizes a dynamic bi-directional applanation process to measure the biomechanical properties of cornea and estimate IOP. A rapid air pulse applies force to the cornea and an advanced electro-optical system monitors corneal deformation. A precisely-metered collimated-air-pulse pushes the cornea inwards, past a flat state and into a slight concavity. Milliseconds after applanation, the air pump shuts off and the pressure gradually declines. As the pressure decreases, the cornea first passes through an applanated state before resuming its original curved structure. The applanation detection system monitors the corneal movement throughout the entire process. Two separate pressure values are derived from the INWARD and OUTWARD applanation events. The difference between these two pressure values is termed CH. This biomechanical property reflects corneal absorption and dissipation of the energy from an applied force. Derived from the measurement of CH is the Corneal resistance factor (CRF). CRF represents the cornea's ability to resist deformation in the presence of an external force.

Goldmann applanation tonometry (Haag-Streit AG, Koeniz, Switzerland) is still recognized as the gold standard for measuring IOP in glaucoma patients and it was performed in all patients at all visits. The ORA takes the CH and CRF measurements into account to generate the corneal-compensated intraocular pressure (IOPcc) value, which is mean to be less affected by corneal biomechanical properties than the Goldmann-IOP. The IOP bias is estimated as the difference between IOPcc and Goldmann-IOP (IOPcc - Goldmann IOP). A positive bias value indicates that the IOPcc is larger than the Goldmann-IOP, meaning that Goldman tonometry underestimated IOP in comparison to the IOPcc.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes

排除标准

  • corneal disease (such as Fuchs' endothelial dystrophy or keratoconus)
  • past history of corneal trauma or surgery (including refractive surgery) that may affect hysteresis measurements
  • contact lens wearers
  • uncontrolled glaucoma or advanced visual field (VF) damage (mean defect < -12.0 db)
  • patients taking systemic prostaglandin medication, non-steroidal anti-inflammatory drugs, or undergoing hormone replacement therapy

研究组 & 干预措施

topical prostaglandin analogs

Other

干预措施: topical prostaglandin analogs (Drug)

结局指标

主要结局

The Corneal Hysteresis (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)

时间窗: 12 weeks

次要结局

  • The Corneal Resistance Factor (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)(12 weeks)
  • The intraocular pressure (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from Goldmann tonometry(12 weeks)
  • The corneal thickness (in µm) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from pachymetry(12 weeks)

研究者

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

Dr. Paul Harasymowycz

Paul Harasymowycz, MD

Maisonneuve-Rosemont Hospital

研究点 (1)

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