Scleritis and EpiscleritisNCT01958567
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
A study testing Optical Coherence Tomography in people with Scleritis and Episcleritis, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
Trial summary
The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleritis and Episcleritis
- What is being tested?
- Optical Coherence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2012to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years any gender
- Patients with clinical signs of scleritis or episcleritis
- Signed informed consent
Who cannot join
- Infectious keratitis or conjunctivitis
- Patients 18 years or younger
- Inability to open the eye
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.
Read the detailed description
A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.
- Conditions
- Scleritis and Episcleritis
- Being tested
- Optical Coherence Tomography
- Keywords
- Scleritis, Episcleritis, Optical coherence Tomography
- Medical subject headings
- Scleritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical signs of scleritis or episcleritis | Experimental | Optical Coherence Tomography for patients with scleral inflammation Receives: Other: Optical Coherence Tomography |
| Normal subjects with normal sclera | Experimental | Optical Coherence Tomography on eyes with normal scleral Receives: Other: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation
To differentiate cases with anterior scleritis from those with episcleritis and normal controls
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleritis and EpiscleritisStudies 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
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958567
- Sponsor's protocol ID
- TEC 125
- Other IDs
- TEC 2013-006 [THE EYE CENTER]
- Status last verified
- Aug 2014
- First submitted
- 7 Oct 2013
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
- ClinicalTrials.gov ID
- NCT01958567
- Acronym / sponsor ID
- TEC 125
- Conditions
- Scleritis and Episcleritis
- Keywords
- Scleritis, Episcleritis, Optical coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in OphthalmologyUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Oct 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 main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.
Detailed description
A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.
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 clinical signs of scleritis or episcleritis | Experimental | Other: Optical Coherence TomographyOptical Coherence Tomography for patients with scleral inflammation |
| Normal subjects with normal sclera | Experimental | Other: Optical Coherence TomographyOptical Coherence Tomography on eyes with normal scleral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 years any gender
- Patients with clinical signs of scleritis or episcleritis
- Signed informed consent
Key exclusion criteria (3 listed)
- Infectious keratitis or conjunctivitis
- Patients 18 years or younger
- Inability to open the eye
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 |
|---|---|---|
| Optical Coherence Tomography | Other | Normal subjects with normal sclera, Patients with clinical signs of scleritis or episcleritis |
Primary outcome
To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation
Time frame: 3 months
To differentiate cases with anterior scleritis from those with episcleritis and normal controls
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.
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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?
A study testing Optical Coherence Tomography in people with Scleritis and Episcleritis, 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?
To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation (time frame: 3 months). 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 1 Sep 2014.