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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
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01254006     History of Changes
Other Study ID Numbers: GLA0110
Study First Received: November 29, 2010
Last Updated: December 3, 2010
Health Authority: Italy: università la sapienza

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Thiamine
Vitamins
 Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013