Diabetic Macular EdemaNCT02063321
Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Emil Martinka.
Trial summary
The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy
- How many people
- 762 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults regularly examined in National Institute of Endocrinology and Diabetology (NIED) for their severity and complications of diabetes will undergo a screening procedure using fundus camera to assess the back of the eye (fundus examination).
Who may be able to join
- Adults ≥18 years treated in National Institute of Endocrinology and Diabetology
- Patients diagnosed with Diabetes mellitus type I and type 2 respectively
- Presence of Diabetes ≥10 years or patients with suspected visual impairment (duration of diabetes <10 years)
- Signed patient´s information and informed content
Who cannot join
- Non-compliant patients
About this study
The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.
Read the detailed description
Epidemiological study, prospective, non-interventional
- Patient with history of diabetes ≥ 10 years or with suspected visual impairment will be enrolled and screened in NIED during hospitalization
- Anamnesis and history of diabetes, other co-morbidities, treatment will be recorded
- Patient undergo in NIED detailed diabetology examination and basic ophthalmology examination (best non-corrected visual acuity in ETDRS score and Amsler grid test)
- Patient undergo in NIED examination of the back of the eye using fundus camera to take images of retina to assess long-term changes of macula, optic disc, retina vessels and surrounding tissues
- The assessment of the ophthalmology examination will be carried out in one of two specialized reading centers - II. Eye Clinic SZU FNsP F.D.R., Banská Bystrica or OFTAL Specialized Hospital for Ophthalmology, Zvolen by Retina specialist
The process of screening will be continuous, whilst each patient will sign an informed consent.
Patients records will be stored electronically and data transmission between NIED and Reading Center will be protected using validated and secured software.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- DME, diabetic retinopathy, diabetes mellitus, epidemiology
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema
Image of fundus taken in NIED securely sent via internet and electronic Clinical Report Form (eCRF) to ophthalmology reading center to assess stage and severity of potential retina damage, feedback to NIED within the stay of screened individual essential for further disease management
Measured: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days
Secondary outcomes (5)
Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes
Measured: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to duration of diabetes
Measured: Patients screened during hospitalization in NIED, usually in 10 days
Prognostic factors, which determine the occurence of DME using explorative analysis
Measured: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to type of diabetes
Measured: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to general treatment (insulin vs. OAD or combination therapy)
Measured: Patients screened during hospitalization in NIED, usually in 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startDec 2012
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emil Martinka
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Slovakia, s.r.o.
- Responsible party
- Sponsor-investigator, Emil Martinka, National Institute of Endocrinology and Diabetology, Slovakia
- Investigators
- Marta Ondrejkova, MD, Study chair, II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska BystricaMonika Gajdosova, MD, Study chair, Oftal, s.r.o. Specialized Hospital for Ophthalmology, ZvolenEmil Martinka, MD, Principal investigator, Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063321
- Sponsor's protocol ID
- LUB012013
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic
- ClinicalTrials.gov ID
- NCT02063321
- Acronym / sponsor ID
- LUB012013
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- DME, diabetic retinopathy, diabetes mellitus, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Emil MartinkaUniversity, hospital or other
- Collaborators
- Novartis Slovakia, s.r.o.
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Feb 2014 (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 aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.
Detailed description
Epidemiological study, prospective, non-interventional
- Patient with history of diabetes ≥ 10 years or with suspected visual impairment will be enrolled and screened in NIED during hospitalization
- Anamnesis and history of diabetes, other co-morbidities, treatment will be recorded
- Patient undergo in NIED detailed diabetology examination and basic ophthalmology examination (best non-corrected visual acuity in ETDRS score and Amsler grid test)
- Patient undergo in NIED examination of the back of the eye using fundus camera to take images of retina to assess long-term changes of macula, optic disc, retina vessels and surrounding tissues
- The assessment of the ophthalmology examination will be carried out in one of two specialized reading centers - II. Eye Clinic SZU FNsP F.D.R., Banská Bystrica or OFTAL Specialized Hospital for Ophthalmology, Zvolen by Retina specialist
The process of screening will be continuous, whilst each patient will sign an informed consent.
Patients records will be stored electronically and data transmission between NIED and Reading Center will be protected using validated and secured software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults regularly examined in National Institute of Endocrinology and Diabetology (NIED) for their severity and complications of diabetes will undergo a screening procedure using fundus camera to assess the back of the eye (fundus examination).
Key inclusion criteria (4 listed)
- Adults ≥18 years treated in National Institute of Endocrinology and Diabetology
- Patients diagnosed with Diabetes mellitus type I and type 2 respectively
- Presence of Diabetes ≥10 years or patients with suspected visual impairment (duration of diabetes <10 years)
- Signed patient´s information and informed content
Key exclusion criteria (1 listed)
- Non-compliant patients
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
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema
Time frame: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days
Image of fundus taken in NIED securely sent via internet and electronic Clinical Report Form (eCRF) to ophthalmology reading center to assess stage and severity of potential retina damage, feedback to NIED within the stay of screened individual essential for further disease management
5 secondary outcomes
Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to duration of diabetes
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Prognostic factors, which determine the occurence of DME using explorative analysis
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to type of diabetes
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to general treatment (insulin vs. OAD or combination therapy)
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Main Site of Principal InvestigatorLink provided by the sponsor.
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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.
Marta Ondrejkova, MD study chair
II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica
Monika Gajdosova, MD study chair
Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen
Emil Martinka, MD principal investigator
Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Emil Martinka.
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 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: status not confirmed, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema (time frame: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days). 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 14 Feb 2014.