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Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

This study has been completed.
Sponsor:
Collaborators:
vingolo enzo maria
domanico daniela
salvatore serena
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01254006
First received: November 29, 2010
Last updated: December 3, 2010
Last verified: August 2009

November 29, 2010
December 3, 2010
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retinal nerve fibres layer thickness
Same as current
Complete list of historical versions of study NCT01254006 on ClinicalTrials.gov Archive Site
global risk threshold for glaucoma progression
Same as current
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Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
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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.

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Interventional
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Glaucoma
Drug: forskolin, rutin and vitamins B1 and B2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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

Both
30 Years to 80 Years
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Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01254006
GLA0110
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University of Roma La Sapienza
  • vingolo enzo maria
  • domanico daniela
  • salvatore serena
Not Provided
University of Roma La Sapienza
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP