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

This study has been terminated.
(short of study staff)
Sponsor:
Information provided by (Responsible Party):
Juliane Matlach, MD, University Eye Hospital, Würzburg
ClinicalTrials.gov Identifier:
NCT01422525
First received: August 21, 2011
Last updated: December 1, 2014
Last verified: December 2014
  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

Resource links provided by NLM:


Further study details as provided by University Eye Hospital, Würzburg:

Primary Outcome Measures:
  • change of retinal nerve fiber layer thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    study was terminated


Enrollment: 12
Study Start Date: November 2011
Primary Completion Date: February 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422525

Locations
Germany
University Eye Hospital Wuerzburg
Wuerzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University Eye Hospital, Würzburg
  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: December 1, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 03, 2015