Ocular ToxoplasmosisNCT04219176
Spectral Optical Coherence Tomography Findings in Patients With Ocular Toxoplasmosis
An observational study of Ocular Toxoplasmosis, run by Université de Sousse.
Trial summary
Ocular toxoplasmosis is the most common cause of infectious uveitis worldwide. The diagnosis of ocular toxoplasmosis is primarily clinical when it is a typical presentation .With an atypical presentation in the fundus, parasitological diagnosis is a decisive contribution, as well as multimodal imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Toxoplasmosis
- What is being tested?
- Spectral optical coherence tomography
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2002to 2 Jan 2018
- 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: Nine eyes of nine patients consecutively diagnosed with ocular toxoplasmosis were included in this retrospective study. The patients were examined at ophthalmology service of Farhat Hached Hospital in Sousse Tunisia between January 2002 and December 2017
Who may be able to join
- all patients hospitalized for ocular toxoplasmosis.
Who cannot join
- patients with non active ocular toxoplasmosis
About this study
Official title: Spectral Optical Coherence Tomography Findings in Patients With Ocular Toxoplasmosis : a Retrospective Study
Ocular toxoplasmosis is the most common cause of infectious uveitis worldwide. The diagnosis of ocular toxoplasmosis is primarily clinical when it is a typical presentation .With an atypical presentation in the fundus, parasitological diagnosis is a decisive contribution, as well as multimodal imaging. We investigate on vitreal, retinal, and choroidal morphologic changes in active and scarred toxoplasmosis lesions using swept source optical coherence tomography.
Read the detailed description
A retrospective analysis of patients diagnosed with ocular toxoplasmosis was conducted. The patients were examined at ophthalmology service of Farhat Hached Hospital in Sousse Tunisia between January 2002 and December 2017. Complete ophthalmologic examination and OCT were done at the initial visit and during follow-up.
- Conditions
- Ocular Toxoplasmosis
- Being tested
- Spectral optical coherence tomography
- Keywords
- Spectral optical coherence tomography, Ocular toxoplasmosis, Uveitis
- Medical subject headings
- Toxoplasmosis, Ocular, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral optical coherence tomographyDiagnostic test
Swept-source optical coherence tomography (SS-OCT) is the latest milestone in retinal and choroidal imaging. Because its wavelength of 1050 nm, which is superior to the 840 nm of spectral domain optical coherence tomography (SD-OCT), it is able to overcome ocular opacities such as cataracts and vitritis, wich allows retinal and choroidal visualization of eyes whose fundus is not clearly visible. Consequently , SS-OCT allows visualization of the retinal and choroidal vascular networks, even in eyes with medium opacity
What is being measured
The primary outcome is the main question the study is designed to answer.
number of prticipant affected with ocular toxoplasmosis
patient diagnosed having ocular toxoplasmosis
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start23 Jan 2002
- Primary completion29 Mar 2017
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular ToxoplasmosisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219176
- Sponsor's protocol ID
- U23454
- Status last verified
- Jan 2020
- First submitted
- 28 Dec 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Optical Coherence Tomography Findings in Patients With Ocular Toxoplasmosis : a Retrospective Study
- ClinicalTrials.gov ID
- NCT04219176
- Acronym / sponsor ID
- U23454
- Conditions
- Ocular Toxoplasmosis
- Keywords
- Spectral optical coherence tomography, Ocular toxoplasmosis, Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 23 Jan 2002 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 6 Jan 2020 (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.
Ocular toxoplasmosis is the most common cause of infectious uveitis worldwide. The diagnosis of ocular toxoplasmosis is primarily clinical when it is a typical presentation .With an atypical presentation in the fundus, parasitological diagnosis is a decisive contribution, as well as multimodal imaging. We investigate on vitreal, retinal, and choroidal morphologic changes in active and scarred toxoplasmosis lesions using swept source optical coherence tomography.
Detailed description
A retrospective analysis of patients diagnosed with ocular toxoplasmosis was conducted. The patients were examined at ophthalmology service of Farhat Hached Hospital in Sousse Tunisia between January 2002 and December 2017. Complete ophthalmologic examination and OCT were done at the initial visit and during follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nine eyes of nine patients consecutively diagnosed with ocular toxoplasmosis were included in this retrospective study. The patients were examined at ophthalmology service of Farhat Hached Hospital in Sousse Tunisia between January 2002 and December 2017
Key inclusion criteria (1 listed)
- all patients hospitalized for ocular toxoplasmosis.
Key exclusion criteria (1 listed)
- patients with non active ocular toxoplasmosis
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 |
|---|---|---|
| Spectral optical coherence tomographySwept-source optical coherence tomography (SS-OCT) is the latest milestone in retinal and choroidal imaging. Because its wavelength of 1050 nm, which is superior to the 840 nm of spectral domain optical coherence tomography (SD-OCT), it is able to overcome ocular opacities such as cataracts and vitritis, wich allows retinal and choroidal visualization of eyes whose fundus is not clearly visible. Consequently , SS-OCT allows visualization of the retinal and choroidal vascular networks, even in eyes with medium opacity | Diagnostic test | – |
Primary outcome
number of prticipant affected with ocular toxoplasmosis
Time frame: up to one year
patient diagnosed having ocular toxoplasmosis
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 Jan 2020.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Toxoplasmosis, run by Université de Sousse.
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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
number of prticipant affected with ocular toxoplasmosis (time frame: up to one year). 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 Jan 2020.