EndophthalmitisNCT02818062
Severe Intraocular Infection
An observational study of Endophthalmitis, run by University Hospital, Strasbourg, France at 7 sites in France.
Trial summary
The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies. The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Cytokines dosage in Aqueous humor
- How many people
- 263 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2008to Sep 2011
- 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: Patients from referral centers coming for post-operative endophthalmitis. Multicenter studies (in France: Strasbourg, Dijon, Grenoble, Nancy).
Who may be able to join
- Post-operative endophthalmitis
- Cataract
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service d'Ophtalmologie, Hôpital Pasteur
Colmar, 68000
Service d'Ophtalmologie, Hôpital Général de Dijon
Dijon, 21000
Service d'Ophtalmologie, Hôpital Michallon
Grenoble, 38043
Service d'Ophtalmologie, Centre Hospitalier de Mulhouse
Mulhouse, 68100
Service d'Ophtalmologie, CHU de Nancy
Nancy, 54000
Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service d'Ophtalmologie, Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.
The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.
- Conditions
- Endophthalmitis
- Being tested
- Cytokines dosage in Aqueous humor
- Keywords
- Endophthalmitis, Cytokines, Chemokines, Inflammation, Regulation
- Medical subject headings
- Endophthalmitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokines dosage in Aqueous humorBiological
Specify details not covered in associated Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Endophthalmitis | The diagnosis of endophthalmitis was made on the basis of clinical features including pain, decreased visual acuity (VA), diffuse bulbar conjunctival hyperaemia, chemosis, inflammation of the anterior segment and posterior segment inflammation (all patients had vitreous infiltration diagnosed by biomicroscopy or ophthalmic ultrasound). Receives: Biological: Cytokines dosage in Aqueous humor | |
| Cataract (Control) | Controls were patients who underwent cataract surgery. Receives: Biological: Cytokines dosage in Aqueous humor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular cytokine network. Intraocular levels of 27 cytokines
Cytokines and chemokines levels in Aqueous humor (AqH) are measured with the Bio-Plex® Multiplex System human Cytokine 27-Plex Panel assay (Bio-Rad, Marne-la-Coquette, France).
The immune mediators were classified in five categories: (a) proinflammatory mediators: (IL-6 and monocyte chemoattractant protein (MCP-1), (b) type 1 cytokines: IL-2, IL-12(p70), Interferon (IFN-γ), and tumor necrosis factor-α (TNF-α), (c) type 2 cytokines: IL-4, IL-10 and IL-13, (d) T-regulatory cytokine: IL-10 and (e) Th-17 cytokine: IL-17. The cytokine and chemokine assay plate layout consisted of a standard series in duplicate (1 to 32 000 pg/ml), four blank wells and 20 μl duplicates of pooled AqH samples, diluted to 50 μl with BioPlex mouse serum diluent. The BioPlex® method was performed as recommended by the manufacturer and previously published studies. Data were analyzed with Bio-Plex Manager software® V 1.1 (Bio-Rad).
Measured: Once in the 24 hours following the admission
Secondary outcomes (1)
Visual acuity
E Snellen Conversion in LogMAR unit
Measured: Once in the 24 hours following the admission, then 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818062
- Sponsor's protocol ID
- 3964
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Intraocular Infection
- ClinicalTrials.gov ID
- NCT02818062
- Acronym / sponsor ID
- 3964
- Conditions
- Endophthalmitis
- Keywords
- Endophthalmitis, Cytokines, Chemokines, Inflammation, Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Jun 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.
The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.
The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endophthalmitis | – | Biological: Cytokines dosage in Aqueous humorThe diagnosis of endophthalmitis was made on the basis of clinical features including pain, decreased visual acuity (VA), diffuse bulbar conjunctival hyperaemia, chemosis, inflammation of the anterior segment and posterior segment inflammation (all patients had vitreous infiltration diagnosed by biomicroscopy or ophthalmic ultrasound). |
| Cataract (Control) | – | Biological: Cytokines dosage in Aqueous humorControls were patients who underwent cataract surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from referral centers coming for post-operative endophthalmitis. Multicenter studies (in France: Strasbourg, Dijon, Grenoble, Nancy).
Key inclusion criteria (2 listed)
- Post-operative endophthalmitis
- Cataract
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cytokines dosage in Aqueous humorSpecify details not covered in associated Arm Description. | Biological | Cataract (Control), Endophthalmitis |
Primary outcome
Intraocular cytokine network. Intraocular levels of 27 cytokines
Time frame: Once in the 24 hours following the admission
Cytokines and chemokines levels in Aqueous humor (AqH) are measured with the Bio-Plex® Multiplex System human Cytokine 27-Plex Panel assay (Bio-Rad, Marne-la-Coquette, France). The immune mediators were classified in five categories: (a) proinflammatory mediators: (IL-6 and monocyte chemoattractant protein (MCP-1), (b) type 1 cytokines: IL-2, IL-12(p70), Interferon (IFN-γ), and tumor necrosis factor-α (TNF-α), (c) type 2 cytokines: IL-4, IL-10 and IL-13, (d) T-regulatory cytokine: IL-10 and (e) Th-17 cytokine: IL-17. The cytokine and chemokine assay plate layout consisted of a standard series in duplicate (1 to 32 000 pg/ml), four blank wells and 20 μl duplicates of pooled AqH samples, diluted to 50 μl with BioPlex mouse serum diluent. The BioPlex® method was performed as recommended by the manufacturer and previously published studies. Data were analyzed with Bio-Plex Manager software® V 1.1 (Bio-Rad).
1 secondary outcome
Visual acuity
Time frame: Once in the 24 hours following the admission, then 3 months, 6 months and 1 year
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 29 Jun 2016.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endophthalmitis, run by University Hospital, Strasbourg, France at 7 sites in France.
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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Intraocular cytokine network. Intraocular levels of 27 cytokines (time frame: Once in the 24 hours following the admission). 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 29 Jun 2016.