Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
December 3, 2010 updated by: University of Roma La Sapienza
In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Latina, Italy
- Univerisity La Sapienza
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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
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age (30-80 years);
- Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period;
- Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit;
- Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report
- Vertical Cup/Disk ratio (0,00-0,80): average of both eyes
- All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator.
Exclusion Criteria:
-other ocular pathologies than glaucoma
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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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retinal nerve fibres layer thickness
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Secondary Outcome Measures
Outcome Measure |
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global risk threshold for glaucoma progression
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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 Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
December 3, 2010
First Posted (Estimate)
December 6, 2010
Study Record Updates
Last Update Posted (Estimate)
December 6, 2010
Last Update Submitted That Met QC Criteria
December 3, 2010
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLA0110
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.