GlaucomaNCT01254006
Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
A study testing forskolin, rutin and vitamins B1 and B2 in people with Glaucoma, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- forskolin, rutin and vitamins B1 and B2
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -other ocular pathologies than glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma
- Being tested
- forskolin, rutin and vitamins B1 and B2
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forskolin, rutin and vitamins B1 and B2Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal nerve fibres layer thickness
Secondary outcomes (1)
global risk threshold for glaucoma progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- vingolo enzo maria, domanico daniela, salvatore serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254006
- Sponsor's protocol ID
- GLA0110
- Status last verified
- Aug 2009
- First submitted
- 29 Nov 2010
- Last updated
- 6 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
- ClinicalTrials.gov ID
- NCT01254006
- Acronym / sponsor ID
- GLA0110
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- vingolo enzo maria, domanico daniela, salvatore serena
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -other ocular pathologies than glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| forskolin, rutin and vitamins B1 and B2 | Drug | – |
Primary outcome
retinal nerve fibres layer thickness
1 secondary outcome
global risk threshold for glaucoma progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forskolin, rutin and vitamins B1 and B2 in people with Glaucoma, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal nerve fibres layer thickness. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.