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Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254006
First Posted: December 6, 2010
Last Update Posted: December 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
vingolo enzo maria
domanico daniela
salvatore serena
Information provided by:
University of Roma La Sapienza
  Purpose
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.

Condition Intervention
Glaucoma Drug: forskolin, rutin and vitamins B1 and B2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • retinal nerve fibres layer thickness

Secondary Outcome Measures:
  • global risk threshold for glaucoma progression

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254006


Locations
Italy
Univerisity La Sapienza
Latina, Italy
Sponsors and Collaborators
University of Roma La Sapienza
vingolo enzo maria
domanico daniela
salvatore serena
  More Information

ClinicalTrials.gov Identifier: NCT01254006     History of Changes
Other Study ID Numbers: GLA0110
First Submitted: November 29, 2010
First Posted: December 6, 2010
Last Update Posted: December 6, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs


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