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

Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography

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.

Study Overview

• Status: Terminated
• Conditions: Optic Nerve Diseases; Nerve Fiber Bundle Defect
• Intervention / Treatment: 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
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97080
      • University Eye Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

glaucoma patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of retinal nerve fiber layer thickness	study was terminated	6 months

Collaborators and Investigators

• Sponsor: University Eye Hospital, Würzburg

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 21, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 24, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases
• Other Study ID Numbers: OCT-TET