Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT06340061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'Intraocular pressure'}, {'measure': 'bIOP', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'Biomechanical intraocular pressure. Corneal Biomechanics Parameters.'}, {'measure': 'ACD', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'Anterior chamber depth. Anterior Chamber Parameters.'}, {'measure': 'ACW', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'Anterior chamber width. Anterior Chamber Parameters.'}, {'measure': 'SSI', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'Stress-strain index. Corneal Biomechanics Parameters.'}, {'measure': 'VF', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'visual field. The severity of glaucoma is mainly based on the damage of the visual field'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of primary glaucoma.\n* Must be able to cooperate to complete the inspection.\n\nExclusion Criteria:\n\n* Secondary glaucoma.\n* Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.\n* trauma\n* congenital eye malformations'}, 'identificationModule': {'nctId': 'NCT06340061', 'briefTitle': 'The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.', 'orgStudyIdInfo': {'id': 'Qianyu Wu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'interventionNames': ['Other: Observational study']}, {'label': 'Control group'}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Qian Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital, Henan Eye Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}