NCT01254006CompletedNot Applicable
Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
University of Roma La Sapienza1 site in 1 countryStarted: December 6, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 1
- Primary Endpoint
- retinal nerve fibres layer thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
retinal nerve fibres layer thickness
Secondary Outcomes
- global risk threshold for glaucoma progression
Investigators
Study Sites (1)
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