Diabetic RetinopathyNCT01131650
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
An observational study of Diabetic Retinopathy, run by Hospital do Olho Rio Preto at 1 site in Brazil.
Trial summary
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil Abstract Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 710 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto
Who may be able to join
- Patients with Diabetes Melittus
Who cannot join
- Patients without Diabetes Melittus
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Carlos Eduardo Cury Junior
São José do Rio Preto, São Paulo, 15090500
About this study
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
Abstract
Read more
Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .
Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)
Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.
Read the detailed description
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
Abstract
Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .
Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)
Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.
Results: Among 710 screened patients 112 had some degree of diabetic retinopathy and the overall standardized prevalence of any retinopathy was 16,3%., including 90 (80,4%) with non-proliferative and (22) 19,6 % with proliferative diabetic retinopathy. Only 143 patients (68,7%) had a history of previous fundoscopic eye examination.
Conclusion: This study demonstrated that DM and their complications are a important public health problem. The duration of DM and glicemic control is strongly associated with DR . Prevention programs with periodic fundoscopic exams shows to diminished the prevalence of this ocular disease.
Keywords: Diabetes, Retinopathy, Prevalence, Population.
- Conditions
- Diabetic Retinopathy
- Keywords
- Prevalence of diabetic retinopathy, Diabetes, Retinopathy, Prevalence, Population
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Retinal Diseases
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 |
|---|---|---|
| diabetic retinopathy | Not described | |
| diabetica retinopathy prevalence | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diabetic retinopathy
Secondary outcomes (1)
associated risk factors of diabetic retinopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionMay 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Olho Rio Preto
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine of Ribeirão Preto (FMRP-USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131650
- Sponsor's protocol ID
- mc201106
- Status last verified
- May 2010
- First submitted
- 26 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
- ClinicalTrials.gov ID
- NCT01131650
- Acronym / sponsor ID
- mc201106
- Conditions
- Diabetic Retinopathy
- Keywords
- Prevalence of diabetic retinopathy, Diabetes, Retinopathy, Prevalence, Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- Hospital do Olho Rio PretoUniversity, hospital or other
- Collaborators
- Faculty of Medicine of Ribeirão Preto (FMRP-USP)
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 May 2010 (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.
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
Abstract
Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .
Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)
Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.
Detailed description
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
Abstract
Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .
Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)
Methods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.
Results: Among 710 screened patients 112 had some degree of diabetic retinopathy and the overall standardized prevalence of any retinopathy was 16,3%., including 90 (80,4%) with non-proliferative and (22) 19,6 % with proliferative diabetic retinopathy. Only 143 patients (68,7%) had a history of previous fundoscopic eye examination.
Conclusion: This study demonstrated that DM and their complications are a important public health problem. The duration of DM and glicemic control is strongly associated with DR . Prevention programs with periodic fundoscopic exams shows to diminished the prevalence of this ocular disease.
Keywords: Diabetes, Retinopathy, Prevalence, Population.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic retinopathy | – | – |
| diabetica retinopathy prevalence | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto
Key inclusion criteria (1 listed)
- Patients with Diabetes Melittus
Key exclusion criteria (1 listed)
- Patients without Diabetes Melittus
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 retinopathy
1 secondary outcome
associated risk factors of 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 27 May 2010.
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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.
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?
An observational study of Diabetic Retinopathy, run by Hospital do Olho Rio Preto 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 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 27 May 2010. 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?
Prevalence of diabetic retinopathy. 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 27 May 2010.