Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02544646|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : December 29, 2017
It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.
In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.
In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.
The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma||Other: Changes in Ocular rigidity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 15, 2018|
Other: Changes in Ocular rigidity
measured before the operation and 28±7 days after the operation
- Change in ocular rigidity [ Time Frame: Baseline and 28±7 days postoperative ]Change in ocular rigidity after surgery
- Fundus pulsation amplitude [ Time Frame: Baseline and 28±7 days postoperative ]
- Ocular pulse amplitude [ Time Frame: Baseline and 28±7 days postoperative ]
- Mean arterial pressure [ Time Frame: Baseline and 28±7 days postoperative ]
- Pulse rate [ Time Frame: Baseline and 28±7 days postoperative ]
- Axial eye length [ Time Frame: Baseline and 28±7 days postoperative ]
- choroidal thickness [ Time Frame: Baseline and 28±7 days postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544646
|Contact: Gerhard Garhoefer, MD||00431/40400 ext email@example.com|
|Contact: Ahmed Bata, MD, MSc||+43140400 firstname.lastname@example.org|
|Department of Clinical Pharmacology, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Gerhard Garhoefer, MD 00431/40400 ext 29880 email@example.com|
|Principal Investigator: Gerhard Garhoefer, MD|