- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488032
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
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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