Exfoliation SyndromeNCT01023997
Central Corneal Thickness in Glaucoma
An observational study of Exfoliation Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Read more about this study
- Who is it for?
- Ages 25 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Exfoliation Syndrome
- How many people
- 700 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2008to Jan 2013
- Phase
- Observational
- 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 25 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals with and without exfoliation
Who may be able to join
- Exfoliation material on pupil
- Intraocular pressure below 21 mm Hg without glaucomatous damage
- Intraocular pressure above 21 mm Hg without glaucomatous damage
- Raised intraocular pressure with glaucomatous damage
Who cannot join
- Corneal disorders
- History of trauma
- Evidence of corneal abnormality that may influence IOP
- Contact lens use
- Corneal surgery
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, 546 36
About this study
Official title: Central Corneal Thickness in Patients With Exfoliation Syndrome, Exfoliative Glaucoma, Exfoliative Glaucoma, Primary Open-angle Glaucoma and Ocular Hypertension
The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.
Read the detailed description
To compare the central corneal thickness measurement in patients with exfoliation, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress. Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate pachymetry measurements in 2 different examinations at the same time of the day (10:00 am) with 3 different pachymeters. The values obtained are correlated with a number of other glaucoma parameters. A thinner cornea may represent a specific attribute and an additional risk factor for patients with exfoliation. Evaluation of corneal thickness is an important exam in the management of patients with exfoliation.
- Conditions
- Exfoliation Syndrome
- Keywords
- corneal thickness, exfoliation
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary open-angle glaucoma | Not described | |
| ocular hypertension patients | Not described | |
| normal controls | Not described | |
| Exfoliation patients | patients with exfoliation syndrome or exfoliative glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
central corneal thickness
Measured: Morning measurement (10:00-11:00)
Secondary outcomes (1)
Visual field, scanning laser polarimetry
Measured: 10:00-11:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exfoliation SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Kostantinos Kaltsos, MD, PhD, Study director, 1st University Dept of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023997
- Sponsor's protocol ID
- A3502
- Status last verified
- May 2014
- First submitted
- 1 Dec 2009
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Corneal Thickness in Patients With Exfoliation Syndrome, Exfoliative Glaucoma, Exfoliative Glaucoma, Primary Open-angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01023997
- Acronym / sponsor ID
- A3502
- Conditions
- Exfoliation Syndrome
- Keywords
- corneal thickness, exfoliation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Dec 2009 (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.
The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.
Detailed description
To compare the central corneal thickness measurement in patients with exfoliation, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress. Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate pachymetry measurements in 2 different examinations at the same time of the day (10:00 am) with 3 different pachymeters. The values obtained are correlated with a number of other glaucoma parameters. A thinner cornea may represent a specific attribute and an additional risk factor for patients with exfoliation. Evaluation of corneal thickness is an important exam in the management of patients with exfoliation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary open-angle glaucoma | – | – |
| ocular hypertension patients | – | – |
| normal controls | – | – |
| Exfoliation patients | – | –patients with exfoliation syndrome or exfoliative glaucoma |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with and without exfoliation
Key inclusion criteria (4 listed)
- Exfoliation material on pupil
- Intraocular pressure below 21 mm Hg without glaucomatous damage
- Intraocular pressure above 21 mm Hg without glaucomatous damage
- Raised intraocular pressure with glaucomatous damage
Key exclusion criteria (5 listed)
- Corneal disorders
- History of trauma
- Evidence of corneal abnormality that may influence IOP
- Contact lens use
- Corneal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
central corneal thickness
Time frame: Morning measurement (10:00-11:00)
1 secondary outcome
Visual field, scanning laser polarimetry
Time frame: 10:00-11:00
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 12 May 2014.
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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.
Kostantinos Kaltsos, MD, PhD study director
1st University Dept of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exfoliation Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 5 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 12 May 2014. 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 Greece. 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?
central corneal thickness (time frame: Morning measurement (10:00-11:00)). 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 12 May 2014.