Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients
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Purpose
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.
The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.
| Condition | Intervention |
|---|---|
|
Nerve Fiber Bundle Defect Optic Nerve Diseases |
Procedure: spectral domain optical coherence tomography |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Trabeculectomy RNFL thickness OCT |
Procedure: spectral domain optical coherence tomography
RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.
|
Detailed Description:
Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.
The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
glaucoma patients
Inclusion Criteria:
- primary or secondary open angle glaucoma
- target intraocular pressure under medical treatment was not reached
- progression of visual loss
- best corrected visual acuity of 20/100 or more
- spherical equivalent refraction of -8.0 to +4.0 D
- perimetry: less than 20% false positive answers
Exclusion Criteria:
- primary or secondary angle closure glaucoma
- congenital glaucoma
- normal tension glaucoma
- neovascular glaucoma
Contacts and Locations| Germany | |
| University Eye Hospital Wuerzburg | Recruiting |
| Wuerzburg, Bavaria, Germany, 97080 | |
| Contact: Juliane Matlach, Dr. + 49 931 201 0 j.matlach@augenklinik.uni-wuerzburg.de | |
| Principal Investigator: Thomas Klink, PD Dr. | |
| Principal Investigator: Juliane Matlach, Dr. | |
More Information
No publications provided
| Responsible Party: | Juliane Matlach, MD, Dr., University Eye Hospital, Würzburg |
| ClinicalTrials.gov Identifier: | NCT01422525 History of Changes |
| Other Study ID Numbers: | OCT-TET |
| Study First Received: | August 21, 2011 |
| Last Updated: | November 13, 2011 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Optic Nerve Diseases Retinal Diseases Cranial Nerve Diseases Nervous System Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013