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

Optic Nerve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01422525
• Other study ID #: OCT-TET
• Status: Terminated
• Phase: N/A
• First received: August 21, 2011
• Last updated: December 1, 2014
• Start date: November 2011

Study information

• Verified date: December 2014
• Source: University Eye Hospital, Würzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nerve Fiber Bundle Defect
• Nervous System Diseases
• Optic Nerve Diseases
• Retinal Diseases

Intervention

Procedure:
• spectral domain optical coherence tomography
RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.

Locations

Country	Name	City	State
Germany	University Eye Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Eye Hospital, Würzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of retinal nerve fiber layer thickness	study was terminated	6 months	No