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NCT01254006 Clinical Trial

Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01254006
Other study ID # GLA0110
Secondary ID
Status Completed
Phase N/A
First received November 29, 2010
Last updated December 3, 2010

Study information
Verified date August 2009
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: università la sapienza
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 30 Years to 80 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• forskolin, rutin and vitamins B1 and B2

Locations
Country Name City State
Italy Univerisity La Sapienza Latina

Sponsors (4)
Lead Sponsor Collaborator
University of Roma La Sapienza domanico daniela, salvatore serena, vingolo enzo maria

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary retinal nerve fibres layer thickness
Secondary global risk threshold for glaucoma progression
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