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

December 8, 2011 updated by: Technische Universität Dresden

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

44

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic University hospital of Dresden

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNFL in different segments
Time Frame: up to 9 Months
RNFL in upper, lower, temporal and nasal segments
up to 9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • EK 322102010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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