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

Sponsor
Technische Universität Dresden (Other)
Overall Status
Completed
CT.gov ID
NCT01488032
Collaborator
(none)
44
Enrollment
8
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Mar 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Nov 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. RNFL in different segments [up to 9 Months]

      RNFL in upper, lower, temporal and nasal segments

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Technische Universität Dresden

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Technische Universität Dresden
    ClinicalTrials.gov Identifier:
    NCT01488032
    Other Study ID Numbers:
    • EK 322102010
    First Posted:
    Dec 8, 2011
    Last Update Posted:
    Dec 9, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Glaucoma
    Low Tension Glaucoma

    Study Results

    No Results Posted as of Dec 9, 2011