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Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958567
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scleritis and Episcleritis Other: Optical Coherence Tomography Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Study Start Date : July 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with clinical signs of scleritis or episcleritis
Optical Coherence Tomography for patients with scleral inflammation
 Other: Optical Coherence Tomography
Experimental: Normal subjects with normal sclera
Optical Coherence Tomography on eyes with normal scleral
 Other: Optical Coherence Tomography


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958567


Locations
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Saudi Arabia
The Eye Center
Riyadh, Saudi Arabia
Sponsors and Collaborators
The Eye Center and The Eye Foundation for Research in Ophthalmology
More Information
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Responsible Party: Samir S. Shoughy, MD, FRCS (Glasg.), Ophthalmologist, The Eye Center and The Eye Foundation for Research in Ophthalmology
ClinicalTrials.gov Identifier: NCT01958567    
Other Study ID Numbers: TEC 125
TEC 2013-006 [THE EYE CENTER]
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology:
Scleritis
Episcleritis
Optical coherence Tomography
Additional relevant MeSH terms:
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Scleritis
Scleral Diseases
Eye Diseases