Back to resultsOptical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Primary Purpose
Scleritis and Episcleritis
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Optical Coherence Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Scleritis and Episcleritis focused on measuring Scleritis, Episcleritis, Optical coherence Tomography
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 years any gender
- Patients with clinical signs of scleritis or episcleritis
- Signed informed consent
Exclusion Criteria:
- Infectious keratitis or conjunctivitis
- Patients 18 years or younger
- Inability to open the eye
Sites / Locations
- The Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with clinical signs of scleritis or episcleritis
Normal subjects with normal sclera
Arm Description
Optical Coherence Tomography for patients with scleral inflammation
Optical Coherence Tomography on eyes with normal scleral
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01958567
First Posted
October 7, 2013
Last Updated
August 29, 2014
Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
1. Study Identification
Unique Protocol Identification Number
NCT01958567
Brief Title
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Official Title
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleritis and Episcleritis
Keywords
Scleritis, Episcleritis, Optical coherence Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with clinical signs of scleritis or episcleritis
Arm Type
Experimental
Arm Description
Optical Coherence Tomography for patients with scleral inflammation
Arm Title
Normal subjects with normal sclera
Arm Type
Experimental
Arm Description
Optical Coherence Tomography on eyes with normal scleral
Intervention Type
Other
Intervention Name(s)
Optical Coherence Tomography
Primary Outcome Measure Information:
Title
To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation
Description
To differentiate cases with anterior scleritis from those with episcleritis and normal controls
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18 years any gender
Patients with clinical signs of scleritis or episcleritis
Signed informed consent
Exclusion Criteria:
Infectious keratitis or conjunctivitis
Patients 18 years or younger
Inability to open the eye
Facility Information:
Facility Name
The Eye Center
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
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