Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-12 @ 2:13 AM
Study NCT ID:
NCT01958567
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2013-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015423', 'term': 'Scleritis'}], 'ancestors': [{'id': 'D015422', 'term': 'Scleral Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-29', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation', 'timeFrame': '3 months', 'description': 'To differentiate cases with anterior scleritis from those with episcleritis and normal controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scleritis', 'Episcleritis', 'Optical coherence Tomography'], 'conditions': ['Scleritis and Episcleritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 years any gender\n* Patients with clinical signs of scleritis or episcleritis\n* Signed informed consent\n\nExclusion Criteria:\n\n* Infectious keratitis or conjunctivitis\n* Patients 18 years or younger\n* Inability to open the eye'}, 'identificationModule': {'nctId': 'NCT01958567', 'briefTitle': 'Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis', 'organization': {'class': 'OTHER', 'fullName': 'The Eye Center and The Eye Foundation for Research in Ophthalmology'}, 'officialTitle': 'Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis', 'orgStudyIdInfo': {'id': 'TEC 125'}, 'secondaryIdInfos': [{'id': 'TEC 2013-006 [THE EYE CENTER]'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with clinical signs of scleritis or episcleritis', 'description': 'Optical Coherence Tomography for patients with scleral inflammation', 'interventionNames': ['Other: Optical Coherence Tomography']}, {'type': 'EXPERIMENTAL', 'label': 'Normal subjects with normal sclera', 'description': 'Optical Coherence Tomography on eyes with normal scleral', 'interventionNames': ['Other: Optical Coherence Tomography']}], 'interventions': [{'name': 'Optical Coherence Tomography', 'type': 'OTHER', 'armGroupLabels': ['Normal subjects with normal sclera', 'Patients with clinical signs of scleritis or episcleritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'The Eye Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Eye Center and The Eye Foundation for Research in Ophthalmology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'Samir S. Shoughy, MD, FRCS (Glasg.)', 'investigatorAffiliation': 'The Eye Center and The Eye Foundation for Research in Ophthalmology'}}}}