Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-06-08 @ 4:42 PM
Study NCT ID:
NCT03758859
Status:
UNKNOWN
Last Update Posted:
2019-09-04
First Post:
2018-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLARITY Imaging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-21', 'releaseDate': '2024-03-13'}], 'estimatedResultsFirstSubmitDate': '2024-03-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-02', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clarity of retinal images obtained by Optical Coherence Tomography.', 'timeFrame': 'immediately after the administration of drops.', 'description': 'Signal strength of OCT scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'OCT image quality is necessary to provide accurate diagnostic information to ophthalmologists. The increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. Given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. The primary objective is to assess the effect of cross-linked sodium hyaluronate on OCT image quality compared to the effect of blinking alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients subjectively deemed to have poor image quality by the photographer\n\nExclusion Criteria:\n\n* Patients with a known adverse reaction to any of the constituents of the XLHA\n* Patients wearing contact lenses\n* Patients who have used eyedrops in the past 2 hours'}, 'identificationModule': {'nctId': 'NCT03758859', 'acronym': 'CLARITY', 'briefTitle': 'CLARITY Imaging Study', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging', 'orgStudyIdInfo': {'id': '18SM4868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sodium hyaluronate eye drops', 'description': 'the randomly allocated eye will receive sodium hyaluronate drops, followed by a repeat OCT scan; images are then evaluated for clarity by the masked assessor.', 'interventionNames': ['Other: sodium hyaluronate eyedrops']}], 'interventions': [{'name': 'sodium hyaluronate eyedrops', 'type': 'OTHER', 'description': 'sodium hyaluronate eyedrops administered - route ocular -topical', 'armGroupLabels': ['sodium hyaluronate eye drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 5QH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Serge Miodragovic', 'role': 'CONTACT', 'email': 'serge.miodragovic1@nhs.net', 'phone': '+44 2033123206', 'phoneExt': '23206'}, {'name': 'Timothy Yap', 'role': 'CONTACT', 'email': 'timothyedward.yap@nhs.net', 'phone': '+44 2033123206', 'phoneExt': '23206'}], 'facility': 'Western Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Serge Miodragovic', 'role': 'CONTACT', 'email': 'serge.miodragovic1@nhs.net', 'phone': '+442033123206', 'phoneExt': '23206'}, {'name': 'Timothy Yap', 'role': 'CONTACT', 'email': 'timothyedward.yap@nhs.net', 'phone': '+442033123206', 'phoneExt': '23206'}], 'overallOfficials': [{'name': 'Timothy Yap', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-13', 'type': 'RELEASE'}, {'date': '2024-08-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}