Diabetic Retinopathy GradingNCT02177747
Smartphone-based Ophthalmoscopy
A study testing Ophthalmoscopy conducted using a smartphone equipped with a compact addon and Smartphone in people with Diabetic Retinopathy Grading, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy Grading
- What is being tested?
- Ophthalmoscopy conducted using a smartphone equipped with a compact addon and Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to Apr 2014
- Phase
- Interventional
- 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
Who may be able to join
- type 1 or 2 diabetes
- ability to provide written informed consent
Who cannot join
- significant optic media opacities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease
A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.
- Conditions
- Diabetic Retinopathy Grading
- Being tested
- Ophthalmoscopy conducted using a smartphone equipped with a compact addon, Smartphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmoscopy conducted using a smartphone equipped with a compact addonOther
SmartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Diabet patients | Experimental | Smartphone ophthalmoscopy followed by traditional slit-lamp dilated ophthalmoscopy Receives: Other: Ophthalmoscopy conducted using a smartphone equipped with a compact addon; Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic retinopathy grading
The grading was performed according to the Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy classification.
Grade 0: no diabetic retinopathy Grade 1: mild non-proliferative diabetic retinopathy Grade 2: average non-proliferative diabetic retinopathy Grade 3: severe non-proliferative diabetic retinopathy Grade 4: proliferative diabetic retinopathy
Measured: The same day as dilated ophthalmic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy GradingStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Luisa Delcassi, Nausica Ghilardi
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177747
- Sponsor's protocol ID
- SMART001
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease
- ClinicalTrials.gov ID
- NCT02177747
- Acronym / sponsor ID
- SMART001
- Conditions
- Diabetic Retinopathy Grading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- Luisa Delcassi, Nausica Ghilardi
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jun 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.
A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabet patients | Experimental | Other: Ophthalmoscopy conducted using a smartphone equipped with a compact addon, Device: SmartphoneSmartphone ophthalmoscopy followed by traditional slit-lamp dilated ophthalmoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 1 or 2 diabetes
- ability to provide written informed consent
Key exclusion criteria (1 listed)
- significant optic media opacities
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 |
|---|---|---|
| Ophthalmoscopy conducted using a smartphone equipped with a compact addon | Other | Diabet patients |
| Smartphone | Device | Diabet patients |
Primary outcome
Diabetic retinopathy grading
Time frame: The same day as dilated ophthalmic examination
The grading was performed according to the Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy classification. Grade 0: no diabetic retinopathy Grade 1: mild non-proliferative diabetic retinopathy Grade 2: average non-proliferative diabetic retinopathy Grade 3: severe non-proliferative diabetic retinopathy Grade 4: proliferative diabetic retinopathy
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 30 Jun 2014.
Related trials for Diabetic Retinopathy Grading
RecruitingObservational study
Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales
Diabetic Retinopathy (DR), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmoscopy conducted using a smartphone equipped with a compact addon and Smartphone in people with Diabetic Retinopathy Grading, run by Università degli Studi di Brescia 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 2 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: finished, as of the sponsor's last update on 30 Jun 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 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?
Diabetic retinopathy grading (time frame: The same day as dilated ophthalmic examination). 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 30 Jun 2014.