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

  • Italy
      • Latina, Italy
        • Univerisity La Sapienza

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
retinal nerve fibres layer thickness

Secondary Outcome Measures

Outcome Measure
global risk threshold for glaucoma progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

vingolo enzo maria
domanico daniela
salvatore serena

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.

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