Diabetic RetinopathyNCT00797134
Retinal Thickness Analysis Using Optical Coherence Tomography
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2008to Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.
Who may be able to join
- Diagnosis of DR
- Females or Males
- Age over 18 years
- Signed Informed Consent Form
Who cannot join
- Cataract or other eye disease that may interfere with fundus examinations
- Vitreous syneresis or posterior vitreous detachment
- Dilatation of the pupil < 5 mm
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.
The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.
The results of this study will be used exclusively for scientific purposes.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
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 |
|---|---|---|
| DR | Diabetic Retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness.
Measured: After visit(s)
Secondary outcomes (1)
Choroidal Thickness
Measured: After visit(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Cunha-Vaz, MD, PhD, Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797134
- Sponsor's protocol ID
- CNTM025AOCT
- Status last verified
- Feb 2015
- First submitted
- 24 Nov 2008
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Thickness Analysis Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00797134
- Acronym / sponsor ID
- CNTM025AOCT
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Nov 2008 (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 main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.
The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.
The results of this study will be used exclusively for scientific purposes.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DR | – | –Diabetic Retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.
Key inclusion criteria (4 listed)
- Diagnosis of DR
- Females or Males
- Age over 18 years
- Signed Informed Consent Form
Key exclusion criteria (3 listed)
- Cataract or other eye disease that may interfere with fundus examinations
- Vitreous syneresis or posterior vitreous detachment
- Dilatation of the pupil < 5 mm
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
Retinal thickness.
Time frame: After visit(s)
1 secondary outcome
Choroidal Thickness
Time frame: After visit(s)
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 3 Feb 2015.
- Related InfoLink 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.
José Cunha-Vaz, MD, PhD principal investigator
Association for Innovation and Biomedical Research on Light and Image
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 Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 3 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 3 Feb 2015. 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 Portugal. 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 thickness. (time frame: After visit(s)). 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 3 Feb 2015.