Clinical Trial: The Impact of Topical Prostaglandins on the Biomechanical Properties of the Cornea in Patients With Open Angle Glaucoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

Instrumen
Sponsor: Maisonneuve-Rosemont Hospital

Current Primary Outcome: 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) [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • 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) [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Maisonneuve-Rosemont Hospital

Dates:
Date Received: December 20, 2014
Date Started: May 2013
Date Completion: June 2015
Last Updated: March 9, 2015
Last Verified: February 2015