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OpenTrials
Completed

NCT Number: NCT01254006

Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity La Sapienza

Latina, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

forskolin, rutin and vitamins B1 and B2

Drug

Primary outcomes

  1. retinal nerve fibres layer thickness

Secondary outcomes

  1. global risk threshold for glaucoma progression

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • domanico daniela
  • salvatore serena
  • vingolo enzo maria

Registry information

Important dates

First posted
Dec 6, 2010
Registry last updated
Dec 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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