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

NCT ID: NCT01422525

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nerve Fiber Bundle Defect Optic Nerve Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trabeculectomy RNFL thickness OCT

spectral domain optical coherence tomography

Intervention Type PROCEDURE

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

Interventions

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spectral domain optical coherence tomography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Eye Hospital, Würzburg

OTHER

Sponsor Role lead

Responsible Party

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Juliane Matlach, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Eye Hospital Wuerzburg

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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OCT-TET

Identifier Type: -

Identifier Source: org_study_id