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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01488032
First received: December 1, 2011
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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
Normal Tension Glaucoma
High Tension Glaucoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • RNFL in different segments [ Time Frame: up to 9 Months ] [ Designated as safety issue: No ]
    RNFL in upper, lower, temporal and nasal segments


Enrollment: 44
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic University hospital of Dresden

Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01488032     History of Changes
Other Study ID Numbers: EK 322102010
Study First Received: December 1, 2011
Last Updated: December 8, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on April 17, 2014