Back to resultsRetinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
forskolin, rutin and vitamins B1 and B2
Sponsored by
About this trial
This is an interventional trial for Glaucoma
Eligibility 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
Sites / Locations
- Univerisity La Sapienza
Outcomes
Primary Outcome Measures
retinal nerve fibres layer thickness
Secondary Outcome Measures
global risk threshold for glaucoma progression
Full Information
NCT ID
NCT01254006
First Posted
November 29, 2010
Last Updated
December 3, 2010
Sponsor
University of Roma La Sapienza
Collaborators
vingolo enzo maria, domanico daniela, salvatore serena
1. Study Identification
Unique Protocol Identification Number
NCT01254006
Brief Title
Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University of Roma La Sapienza
Collaborators
vingolo enzo maria, domanico daniela, salvatore serena
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
forskolin, rutin and vitamins B1 and B2
Primary Outcome Measure Information:
Title
retinal nerve fibres layer thickness
Secondary Outcome Measure Information:
Title
global risk threshold for glaucoma progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Facility Information:
Facility Name
Univerisity La Sapienza
City
Latina
Country
Italy
12. IPD Sharing Statement
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Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
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