Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 7:41 PM
Study NCT ID:
NCT05271734
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2022-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limbus Exposure', 'timeFrame': 'Baseline', 'description': 'Full 360° Limbus exposure while subject is sitting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['OAG - Open-Angle Glaucoma']}, 'descriptionModule': {'briefSummary': "Direct Selective Laser Trabeculoplasty (DSLT) is an emerging therapeutic technology to treat glaucoma. DSLT was previously tested in 2 clinical trials and demonstrated promising safety and efficacy results in reducing the patient's intra ocular pressure.\n\nExperience gained in the previous clinical studies indicates that a full exposure of the limbal area may be a challenge in patients with narrow palpebral fissures, narrow or floppy eyelids, and patients with deep-set eyes.", 'detailedDescription': 'The DSLT procedure is carried out in the doctor\'s office while the patient sits in front of the DSLT device (termed the "Eagle" device) for couple of minutes.\n\nIn this procedure, 120 laser applications are performed around the full circumference of the ocular limbus, after the system automatically recognizes the limbal target area. It is therefore essential that a full exposure of 3600 limbal area will be achieved, and this is done by placing an eye lid retractor (speculum) in the treated eye at the beginning of the procedure.\n\nThe purpose of this study is to evaluate the compatibility of different types of lid retractors. The lid retractors will be tested in adult volunteers visiting the study eye clinic for any reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria.\n\n* Adult volunteers (age ≥18 years old) of both sexes visiting the study eye clinic for any reason.\n* Willing and able to participate in the study and to comply with the study procedures.\n* Participant capable of giving informed consent.\n\nExclusion Criteria:\n\n* Prior incisional ocular surgery or ocular trauma in the tested eye.\n* Women who are pregnant.\n* Any medical condition that interferes with the subject's ability to sit steady in front of the Eagle device.\n* Known allergy to local anaesthesia eye drops."}, 'identificationModule': {'nctId': 'NCT05271734', 'briefTitle': 'Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'BelkinVision'}, 'officialTitle': 'Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure', 'orgStudyIdInfo': {'id': '2021-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm -lid retractor placement', 'description': 'Placement of a lid retractor the find out if the corneal limbus is exposed to 360 degrees', 'interventionNames': ['Device: Lid retractor placement']}], 'interventions': [{'name': 'Lid retractor placement', 'type': 'DEVICE', 'description': 'Insertion of a lid retractor to find out if the corneal limbus is exposed in 360 degress', 'armGroupLabels': ['Single arm -lid retractor placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Akhali Mzera Eye Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BelkinVision', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}