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

• Sponsor: University Eye Hospital, Würzburg (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01422525
• Collaborator: (none)
• Enrollment: 12
• Location: 1

Study Details

Study Description

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	Phase
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 Design

• 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: Nov 1, 2011
• Actual Primary Completion Date: Feb 1, 2012

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. change of retinal nerve fiber layer thickness [6 months]

   study was terminated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Eye Hospital Wuerzburg	Wuerzburg	Bavaria	Germany	97080

Sponsors and Collaborators

• University Eye Hospital, Würzburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juliane Matlach, MD, Dr., University Eye Hospital, Würzburg
• ClinicalTrials.gov Identifier: NCT01422525
• Other Study ID Numbers: OCT-TET
• First Posted: Aug 24, 2011
• Last Update Posted: Dec 2, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Nervous System Diseases; Optic Nerve Diseases

Study Results

No Results Posted as of Dec 2, 2014