UveitisNCT01905579
Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
A study testing Paracentesis of the anterior chamber in people with Uveitis, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
Trial summary
The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Paracentesis of the anterior chamber
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2013to Aug 2013
- Phase
- Interventional
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 10 patients with uveitis with cataract
- 10 patients without uveitis with cataract
- Inactive inflammation for at least 3 months
Who cannot join
- Infectious uveitis
- endophthalmitis
- cases with corneal scar
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.
Read the detailed description
A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.
- Conditions
- Uveitis
- Being tested
- Paracentesis of the anterior chamber
- Keywords
- flaremetry, aqueous proteins, clinical grading, Compare flaremetry readings with the protein content of the aqueous, Compare flaremetry readings with clinical grading of flare
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracentesis of the anterior chamberProcedure or surgery
Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.
| Study group | Role | What they receive |
|---|---|---|
| patients with uveitis | Experimental | Paracentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery Receives: Procedure: Paracentesis of the anterior chamber |
| patients without uveitis | Experimental | Paracentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery Receives: Procedure: Paracentesis of the anterior chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare flaremetry readings with the protein content of the aqueous humor
Compare flaremetry readings with the protein content of the aqueous and the clinical grading.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
- Investigators
- Samir S Shoughy, Principal investigator, THE EYE CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905579
- Sponsor's protocol ID
- TEC 123
- Other IDs
- TEC 2012-003
- Status last verified
- Aug 2014
- First submitted
- 18 Jul 2013
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shoughy SS, Elkum N, Tabbara KF. Aqueous protein level and flare grading. Acta Ophthalmol. 2015 Mar;93(2):e173-4. doi: 10.1111/aos.12522. Epub 2014 Aug 31. No abstract available.
PubMed 25175512
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
- ClinicalTrials.gov ID
- NCT01905579
- Acronym / sponsor ID
- TEC 123
- Conditions
- Uveitis
- Keywords
- flaremetry, aqueous proteins, clinical grading, Compare flaremetry readings with the protein content of the aqueous, Compare flaremetry readings with clinical grading of flare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in OphthalmologyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Jul 2013 (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 compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.
Detailed description
A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with uveitis | Experimental | Procedure: Paracentesis of the anterior chamberParacentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery |
| patients without uveitis | Experimental | Procedure: Paracentesis of the anterior chamberParacentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 10 patients with uveitis with cataract
- 10 patients without uveitis with cataract
- Inactive inflammation for at least 3 months
Key exclusion criteria (3 listed)
- Infectious uveitis
- endophthalmitis
- cases with corneal scar
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 |
|---|---|---|
| Paracentesis of the anterior chamberAqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis. | Procedure or surgery | patients with uveitis, patients without uveitis |
Primary outcome
compare flaremetry readings with the protein content of the aqueous humor
Time frame: one month
Compare flaremetry readings with the protein content of the aqueous and the clinical grading.
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 1 Sep 2014.
- Derived from this study: PubMed 25175512Shoughy SS, Elkum N, Tabbara KF. Aqueous protein level and flare grading. Acta Ophthalmol. 2015 Mar;93(2):e173-4. doi: 10.1111/aos.12522. Epub 2014 Aug 31. No abstract available.
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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.
Samir S Shoughy principal investigator
THE EYE CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracentesis of the anterior chamber in people with Uveitis, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
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 3 inclusion and 3 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 1 Sep 2014. 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 Saudi Arabia. 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?
compare flaremetry readings with the protein content of the aqueous humor (time frame: one month). 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 NCT01905579, which also lists 1 linked publication.
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 1 Sep 2014.