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

Tracking Information
First Received Date ^ICMJE	November 29, 2010
Last Updated Date	December 3, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: December 3, 2010)	retinal nerve fibres layer thickness
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01254006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 3, 2010)	global risk threshold for glaucoma progression
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Drug: forskolin, rutin and vitamins B1 and B2
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 80 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01254006
Other Study ID Numbers ^ICMJE	GLA0110
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	University of Roma La Sapienza
Collaborators ^ICMJE	vingolo enzo maria domanico daniela salvatore serena
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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