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NCT01488032 Clinical Trial

Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma

Normal Tension Glaucoma Clinical Trial

Official title:
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma With Similar Structural Optic Nerve Damage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01488032
Other study ID # EK 322102010
Secondary ID
Status Completed
Phase N/A
First received December 1, 2011
Last updated December 8, 2011
Start date March 2011
Est. completion date November 2011

Study information
Verified date December 2011
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.

Description:

It is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in patients with normal- and high-tension-glaucoma. In order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- persons over 18 years

- men or women

- with normal- and high-tension glaucoma

Exclusion Criteria:

- cataract

- cloudy cornea and other conditions with bad visualisation quality of optic nerve head

- optic nerve atrophy except glaucomatous

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Outcome
Type Measure Description Time frame Safety issue
Primary RNFL in different segments RNFL in upper, lower, temporal and nasal segments up to 9 Months No
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