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Clinical Trials/NCT01254006
NCT01254006
Completed
Not Applicable

Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

University of Roma La Sapienza1 site in 1 countryDecember 6, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
University of Roma La Sapienza
Locations
1
Primary Endpoint
retinal nerve fibres layer thickness
Status
Completed
Last Updated
15 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2010
End Date
TBD
Last Updated
15 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
University of Roma La Sapienza

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

Outcomes

Primary Outcomes

retinal nerve fibres layer thickness

Secondary Outcomes

  • global risk threshold for glaucoma progression

Study Sites (1)

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