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Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients

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ClinicalTrials.gov Identifier: NCT01422525
Recruitment Status : Terminated (short of study staff)
First Posted : August 24, 2011
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Juliane Matlach, MD, University Eye Hospital, Würzburg

Brief Summary:

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 or disease Intervention/treatment
Nerve Fiber Bundle Defect Optic Nerve Diseases Procedure: spectral domain optical coherence tomography

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.


Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography
Study Start Date : November 2011
Actual Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. change of retinal nerve fiber layer thickness [ Time Frame: 6 months ]
    study was terminated



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
glaucoma patients
Criteria

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

Information from the National Library of Medicine

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): NCT01422525


Locations
Germany
University Eye Hospital Wuerzburg
Wuerzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University Eye Hospital, Würzburg

Responsible Party: Juliane Matlach, MD, Dr., University Eye Hospital, Würzburg
ClinicalTrials.gov Identifier: NCT01422525     History of Changes
Other Study ID Numbers: OCT-TET
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Nervous System Diseases
Optic Nerve Diseases
Retinal Diseases
Cranial Nerve Diseases
Eye Diseases