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

NCT01422525 | Terminated

• 1 other identifier: OCT-TET
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Fiber Bundle Defect; Optic Nerve Diseases

Outcome Measures

Primary Outcomes (1)

• change of retinal nerve fiber layer thickness

  study was terminated

  6 months

Study Arms (1)

Trabeculectomy RNFL thickness OCT

Procedure: spectral domain optical coherence tomography

Interventions

spectral domain optical coherence tomography PROCEDURE

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

Trabeculectomy RNFL thickness OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

glaucoma patients

You may qualify if:

• 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

You may not qualify if:

• primary or secondary angle closure glaucoma
• congenital glaucoma
• normal tension glaucoma
• neovascular glaucoma

Sponsors & Collaborators

• University Eye Hospital, Würzburg: lead

Study Sites (1)

University Eye Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 21, 2011
• First Posted: August 24, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

DE (1)