Diabetic RetinopathyNCT02927561
Automated Diagnostic Test for Diabetic Retinopathy in Brazilian Mass Screening
An observational study of Diabetic Retinopathy, run by Retina Clinic, Sao Paulo, Brazil at 1 site in Brazil.
Trial summary
In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR). Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Diabetic Retinopathy screening
- How many people
- 220 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Sep 2016
- 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: Patients with diabetic retinopathy.
Who may be able to join
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
Who cannot join
- Previous cataract, trabeculectomy or vitrectomy
- Aphakia
- External ocular infections
- Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR). Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system. The automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders.
Read the detailed description
In the South and Central America Region, an estimated 9.4% of the adult population (20-79 years) has diabetes in 2015, and Brazil is the first country in number of people with diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR)(1).
The rising number of people with diabetes in the world has become a real challenge for the public health system to provide care for patients with DR and for people with diabetes at risk for this complication(2). A large proportion of patients with diabetes was inadequately controlled in Brazil, which may contribute to increased rates of diabetic complications (3).
The detection of any degree of DR may result in improved medical monitoring and optimization of risk factors, delaying the progression of the disease(4). In Brazil, the great demand in the public service causes delay in early diagnosis, worsening health status of patients with diabetic retinopathy and increasing the cost of their treatment.
Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system.
Several studies have shown that systematic screening for DR is an effective way of prevention (5). Furthermore, the automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders(6). There are no reports on automated DR detection in Brazilian population, especially in screening campaigns with large-scale diagnosis.
- Conditions
- Diabetic Retinopathy
- Being tested
- Diabetic Retinopathy screening
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Retinopathy screeningOther
Diabetic Retinopathy screening
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the sensitivity and specificity of automated grading system versus human grading in detecting diabetic retinopathy
The aim of this study is to determine the sensitivity and specificity of automated grading system in detecting diabetic retinopathy compared with human grading on the population of annual massive screening campaign for diabetes conducted in the Northeast of Brazil.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Clinic, Sao Paulo, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Andrade, M.D., Study director, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927561
- Sponsor's protocol ID
- Retina C
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mendes AB, Fittipaldi JA, Neves RC, Chacra AR, Moreira ED Jr. Prevalence and correlates of inadequate glycaemic control: results from a nationwide survey in 6,671 adults with diabetes in Brazil. Acta Diabetol. 2010 Jun;47(2):137-45. doi: 10.1007/s00592-009-0138-z. Epub 2009 Aug 5.
PubMed 19655083Soto-Pedre E, Navea A, Millan S, Hernaez-Ortega MC, Morales J, Desco MC, Perez P. Evaluation of automated image analysis software for the detection of diabetic retinopathy to reduce the ophthalmologists' workload. Acta Ophthalmol. 2015 Feb;93(1):e52-6. doi: 10.1111/aos.12481. Epub 2014 Jun 30.
PubMed 24975456Scotland GS, McNamee P, Philip S, Fleming AD, Goatman KA, Prescott GJ, Fonseca S, Sharp PF, Olson JA. Cost-effectiveness of implementing automated grading within the national screening programme for diabetic retinopathy in Scotland. Br J Ophthalmol. 2007 Nov;91(11):1518-23. doi: 10.1136/bjo.2007.120972. Epub 2007 Jun 21.
PubMed 17585001Fleming AD, Philip S, Goatman KA, Olson JA, Sharp PF. Automated assessment of diabetic retinal image quality based on clarity and field definition. Invest Ophthalmol Vis Sci. 2006 Mar;47(3):1120-5. doi: 10.1167/iovs.05-1155.
PubMed 16505050Malerbi FK, Morales PH, Farah ME, Drummond KR, Mattos TC, Pinheiro AA, Mallmann F, Perez RV, Leal FS, Gomes MB, Dib SA; Brazilian Type 1 Diabetes Study Group. Comparison between binocular indirect ophthalmoscopy and digital retinography for diabetic retinopathy screening: the multicenter Brazilian Type 1 Diabetes Study. Diabetol Metab Syndr. 2015 Dec 21;7:116. doi: 10.1186/s13098-015-0110-8. eCollection 2015.
PubMed 26697120Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.
PubMed 2062513Ribeiro L, Oliveira CM, Neves C, Ramos JD, Ferreira H, Cunha-Vaz J. Screening for Diabetic Retinopathy in the Central Region of Portugal. Added Value of Automated 'Disease/No Disease' Grading. Ophthalmologica. 2014 Nov 26. doi: 10.1159/000368426. Online ahead of print.
PubMed 25427567Bhaskaranand M, Ramachandra C, Bhat S, Cuadros J, Nittala MG, Sadda S, Solanki K. Automated Diabetic Retinopathy Screening and Monitoring Using Retinal Fundus Image Analysis. J Diabetes Sci Technol. 2016 Feb 16;10(2):254-61. doi: 10.1177/1932296816628546.
PubMed 26888972
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Diagnostic Test for Diabetic Retinopathy in Brazilian Mass Screening
- ClinicalTrials.gov ID
- NCT02927561
- Acronym / sponsor ID
- Retina C
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Retina Clinic, Sao Paulo, BrazilUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Oct 2016 (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.
In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR). Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system. The automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders.
Detailed description
In the South and Central America Region, an estimated 9.4% of the adult population (20-79 years) has diabetes in 2015, and Brazil is the first country in number of people with diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR)(1).
The rising number of people with diabetes in the world has become a real challenge for the public health system to provide care for patients with DR and for people with diabetes at risk for this complication(2). A large proportion of patients with diabetes was inadequately controlled in Brazil, which may contribute to increased rates of diabetic complications (3).
The detection of any degree of DR may result in improved medical monitoring and optimization of risk factors, delaying the progression of the disease(4). In Brazil, the great demand in the public service causes delay in early diagnosis, worsening health status of patients with diabetic retinopathy and increasing the cost of their treatment.
Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system.
Several studies have shown that systematic screening for DR is an effective way of prevention (5). Furthermore, the automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders(6). There are no reports on automated DR detection in Brazilian population, especially in screening campaigns with large-scale diagnosis.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic retinopathy.
Key inclusion criteria (1 listed)
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
Key exclusion criteria (5 listed)
- Previous cataract, trabeculectomy or vitrectomy
- Aphakia
- External ocular infections
- Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Diabetic Retinopathy screeningDiabetic Retinopathy screening | Other | – |
Primary outcome
To compare the sensitivity and specificity of automated grading system versus human grading in detecting diabetic retinopathy
Time frame: 6 months
The aim of this study is to determine the sensitivity and specificity of automated grading system in detecting diabetic retinopathy compared with human grading on the population of annual massive screening campaign for diabetes conducted in the Northeast of Brazil.
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 7 Oct 2016.
- Results publication: PubMed 19655083Mendes AB, Fittipaldi JA, Neves RC, Chacra AR, Moreira ED Jr. Prevalence and correlates of inadequate glycaemic control: results from a nationwide survey in 6,671 adults with diabetes in Brazil. Acta Diabetol. 2010 Jun;47(2):137-45. doi: 10.1007/s00592-009-0138-z. Epub 2009 Aug 5.
- Results publication: PubMed 24975456Soto-Pedre E, Navea A, Millan S, Hernaez-Ortega MC, Morales J, Desco MC, Perez P. Evaluation of automated image analysis software for the detection of diabetic retinopathy to reduce the ophthalmologists' workload. Acta Ophthalmol. 2015 Feb;93(1):e52-6. doi: 10.1111/aos.12481. Epub 2014 Jun 30.
- Results publication: PubMed 17585001Scotland GS, McNamee P, Philip S, Fleming AD, Goatman KA, Prescott GJ, Fonseca S, Sharp PF, Olson JA. Cost-effectiveness of implementing automated grading within the national screening programme for diabetic retinopathy in Scotland. Br J Ophthalmol. 2007 Nov;91(11):1518-23. doi: 10.1136/bjo.2007.120972. Epub 2007 Jun 21.
- Results publication: PubMed 16505050Fleming AD, Philip S, Goatman KA, Olson JA, Sharp PF. Automated assessment of diabetic retinal image quality based on clarity and field definition. Invest Ophthalmol Vis Sci. 2006 Mar;47(3):1120-5. doi: 10.1167/iovs.05-1155.
- Results publication: PubMed 26697120Malerbi FK, Morales PH, Farah ME, Drummond KR, Mattos TC, Pinheiro AA, Mallmann F, Perez RV, Leal FS, Gomes MB, Dib SA; Brazilian Type 1 Diabetes Study Group. Comparison between binocular indirect ophthalmoscopy and digital retinography for diabetic retinopathy screening: the multicenter Brazilian Type 1 Diabetes Study. Diabetol Metab Syndr. 2015 Dec 21;7:116. doi: 10.1186/s13098-015-0110-8. eCollection 2015.
- Results publication: PubMed 2062513Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.
- Results publication: PubMed 25427567Ribeiro L, Oliveira CM, Neves C, Ramos JD, Ferreira H, Cunha-Vaz J. Screening for Diabetic Retinopathy in the Central Region of Portugal. Added Value of Automated 'Disease/No Disease' Grading. Ophthalmologica. 2014 Nov 26. doi: 10.1159/000368426. Online ahead of print.
- Results publication: PubMed 26888972Bhaskaranand M, Ramachandra C, Bhat S, Cuadros J, Nittala MG, Sadda S, Solanki K. Automated Diabetic Retinopathy Screening and Monitoring Using Retinal Fundus Image Analysis. J Diabetes Sci Technol. 2016 Feb 16;10(2):254-61. doi: 10.1177/1932296816628546.
- Individual participant dataSharing planned: No
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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.
Gabriel Andrade, M.D. study director
Research Director
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 Retina Clinic, Sao Paulo, Brazil at 1 site in Brazil.
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 1 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 7 Oct 2016. 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 Brazil. 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?
To compare the sensitivity and specificity of automated grading system versus human grading in detecting diabetic retinopathy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927561, which also lists 8 linked publications.
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 7 Oct 2016.