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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488032
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : December 9, 2011
Information provided by (Responsible Party):
Technische Universität Dresden

Brief 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.

Condition or disease
Normal Tension Glaucoma High Tension Glaucoma

Detailed 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.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma With Similar Structural Optic Nerve Damage
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

high-tension glaucoma
subjects with IOP>22 mmHg without eyedrops and signs of glaucomatous optic nerve damage
low-tension glaucoma
subjects with IOP<22 mmHg without eyedrops and signs of glaucomatous optic nerve damage

Primary Outcome Measures :
  1. RNFL in different segments [ Time Frame: up to 9 Months ]
    RNFL in upper, lower, temporal and nasal segments

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic University hospital of Dresden

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

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Responsible Party: Technische Universität Dresden Identifier: NCT01488032     History of Changes
Other Study ID Numbers: EK 322102010
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases