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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Ocular Hypertension
Optic Nerve Diseases

ClinicalTrials.gov processed this record on October 22, 2014