KeratitisNCT00949468
Microbiological Keratitis in a Countryside City of Brazil
An observational study of Keratitis, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
Trial summary
The purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratitis
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Jul 2009
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 37 patients admitted in two referral ophthalmology centers in a countryside city of Brazil. 37 volunteers were used as a control group.
Who may be able to join
- All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group)
- 37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group)
Who cannot join
- In the Control Study Group, no infectious ocular disease was accepted
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Jose do Rio Preto University
São José do Rio Preto, São Paulo, 15090000
About this study
Official title: Epidemiologic Characteristics, Predisposing Factors and Microbiological Profile of Infectious Corneal Ulcers in Two Referral Centers in a Countryside City of Brazil
The purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.
- Conditions
- Keratitis
- Keywords
- Keratitis
- Medical subject headings
- Keratitis
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 |
|---|---|---|
| Keratitis group | 37 patients with keratitis | |
| Control Study Group | 37 control volunteers |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Thiago Lo Genaro, Academic, Principal investigator, Sao Jose do Rio Preto Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949468
- Sponsor's protocol ID
- Opht2009
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Characteristics, Predisposing Factors and Microbiological Profile of Infectious Corneal Ulcers in Two Referral Centers in a Countryside City of Brazil
- ClinicalTrials.gov ID
- NCT00949468
- Acronym / sponsor ID
- Opht2009
- Conditions
- Keratitis
- Keywords
- Keratitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Jul 2009 (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 purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keratitis group | – | –37 patients with keratitis |
| Control Study Group | – | –37 control volunteers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 37 patients admitted in two referral ophthalmology centers in a countryside city of Brazil. 37 volunteers were used as a control group.
Key inclusion criteria (2 listed)
- All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group)
- 37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group)
Key exclusion criteria (1 listed)
- In the Control Study Group, no infectious ocular disease was accepted
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
Not reported in the source record.
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 Jul 2009.
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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.
Thiago Lo Genaro, Academic principal investigator
Sao Jose do Rio Preto Medical School
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 Keratitis, run by Sao Jose do Rio Preto Medical School 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 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 Jul 2009. 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.
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 Jul 2009.