Corneal DystrophyNCT01084850
Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
An observational study of Corneal Dystrophy, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corneal Dystrophy
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Sep 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients visiting Frederiksberg hospital for any reason
Who may be able to join
- Type II diabetes (diagnose confirmed by general practitioner)
- Controls with no diabetes (confirmed by blood testing).
Who cannot join
- Glaucoma
- Uveitis (current or previous)
- Corneal scaring
- Previous eye surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Frederiksberg University Eye Clinque
Frederiksberg, Frederiksberg, 2000
Allan Storr-Paulsen, MD, +4538163646, allanstorr@dadlnet.dk
About this study
The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.
Read the detailed description
Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").
- Conditions
- Corneal Dystrophy
- Keywords
- Corneal endothelium, diabetes mellitus, corneal thickness
- Medical subject headings
- Corneal Dystrophies, Hereditary, Diabetes Mellitus
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 |
|---|---|---|
| Diabetes Type II | Patients with type 2 Diabetes Mellitus | |
| Control | Patients with no diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelium cell number
The study is a cross-sectional study. We compare a cohort of patients with DM to a cohort with no DM. We examine each patient and control once. We call time of appointment or examination for "at entry to study".
Measured: 1 year
Secondary outcomes (1)
Corneal endothelium morphology
The size and hexagonality of the cells are analysed automaticly by computer recognizion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DystrophyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jens C Norregaard, MD, phd, Study chair, Frederiksberg University Hospital, Eye Clinque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084850
- Sponsor's protocol ID
- FH5
- Status last verified
- Jan 2010
- First submitted
- 25 Feb 2010
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
- ClinicalTrials.gov ID
- NCT01084850
- Acronym / sponsor ID
- FH5
- Conditions
- Corneal Dystrophy
- Keywords
- Corneal endothelium, diabetes mellitus, corneal thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 11 Mar 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.
The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.
Detailed description
Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Type II | – | –Patients with type 2 Diabetes Mellitus |
| Control | – | –Patients with no diabetes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visiting Frederiksberg hospital for any reason
Key inclusion criteria (2 listed)
- Type II diabetes (diagnose confirmed by general practitioner)
- Controls with no diabetes (confirmed by blood testing).
Key exclusion criteria (4 listed)
- Glaucoma
- Uveitis (current or previous)
- Corneal scaring
- Previous eye 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
Corneal endothelium cell number
Time frame: 1 year
The study is a cross-sectional study. We compare a cohort of patients with DM to a cohort with no DM. We examine each patient and control once. We call time of appointment or examination for "at entry to study".
1 secondary outcome
Corneal endothelium morphology
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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.
Jens C Norregaard, MD, phd study chair
Frederiksberg University Hospital, Eye Clinque
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 Corneal Dystrophy, run by Frederiksberg University Hospital at 1 site in Denmark.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Mar 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Storr-Paulsen, MD (+4538163646, allanstorr@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal endothelium cell number (time frame: 1 year). 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 11 Mar 2010.