Diabetes MellitusNCT04992325
AS-OCT Study in Diabetic Retinopathy
An observational study of Diabetes Mellitus, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Anterior segment-optical coherence tomography
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 30 Apr 2021
- 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 50 to 60 years
- All sexes
- Adult
Study population: The participans were older than 50 years with previous diagnosis of type 2 diabetes mellitus without signs of diabetic retinopathy. The participans did not present other ophthalmological diseases
Who may be able to join
- age older than 50 years
- diagnosis of previous type 2 diabetes mellitus
- absence of signs of diabetic retinopathy
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images
Who cannot join
- age younger than 50 years
- absence of previous diagnosis of type 2 diabetes mellitus
- presence of signs of diabetic retinopathy
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus
Read the detailed description
To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination.
The AS-OCT could represents a valid early biomarker in these patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Anterior segment-optical coherence tomography
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior segment-optical coherence tomographyDiagnostic test
Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes mellitus | The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy Receives: Diagnostic Test: Anterior segment-optical coherence tomography | |
| Healthy subjects | Healthy subjects without actual and previous ocular diseases Receives: Diagnostic Test: Anterior segment-optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography
The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jul 2020
- Primary completion25 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992325
- Sponsor's protocol ID
- 2021/07
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04992325
- Acronym / sponsor ID
- 2021/07
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- 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.
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus
Detailed description
To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination.
The AS-OCT could represents a valid early biomarker in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes mellitus | – | Diagnostic Test: Anterior segment-optical coherence tomographyThe patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy |
| Healthy subjects | – | Diagnostic Test: Anterior segment-optical coherence tomographyHealthy subjects without actual and previous ocular diseases |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participans were older than 50 years with previous diagnosis of type 2 diabetes mellitus without signs of diabetic retinopathy. The participans did not present other ophthalmological diseases
Key inclusion criteria (5 listed)
- age older than 50 years
- diagnosis of previous type 2 diabetes mellitus
- absence of signs of diabetic retinopathy
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images
Key exclusion criteria (5 listed)
- age younger than 50 years
- absence of previous diagnosis of type 2 diabetes mellitus
- presence of signs of diabetic retinopathy
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
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 |
|---|---|---|
| Anterior segment-optical coherence tomographyEach subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses. | Diagnostic test | Healthy subjects, Patients with type 2 diabetes mellitus |
Primary outcome
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography
Time frame: twelve months
The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses
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 5 Aug 2021.
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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.
Gilda Cennamo principal investigator
Federico II University
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 Diabetes Mellitus, run by Federico II University 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 5 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 5 Aug 2021. 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?
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography (time frame: twelve months). 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 5 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.