Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05748002
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stable', 'timeFrame': 'one year', 'description': 'No alterations in morphological(Pentacam parameters, BAD\\<0.42, TCT\\<10μm) and biomechanical(Corvis ST, parametersCBI\\<0.2, SPA1\\<10) parameters between the first and last follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus, Stable']}, 'descriptionModule': {'briefSummary': 'To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients premedicated for refractive surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Best corrected visual acuity (BCVA) ≥ 20/20;\n2. No other eye diseases except myopia and astigmatism;\n3. The cornea was transparent, and there was no cloud or pannus;\n4. No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring） Exclusion Criteria:1) corneal disease;\n\n2\\) ocular trauma; 3) Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 4) Pregnant and lactating women;'}, 'identificationModule': {'nctId': 'NCT05748002', 'briefTitle': 'Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index', 'orgStudyIdInfo': {'id': '2023002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stable group', 'interventionNames': ['Other: Pentacam and Corvis ST']}, {'label': 'subclinical keratoconus', 'interventionNames': ['Other: Pentacam and Corvis ST']}, {'label': 'normal group', 'interventionNames': ['Other: Pentacam and Corvis ST']}, {'label': 'follow up group', 'interventionNames': ['Other: Pentacam and Corvis ST']}], 'interventions': [{'name': 'Pentacam and Corvis ST', 'type': 'OTHER', 'description': 'morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST', 'armGroupLabels': ['follow up group', 'normal group', 'stable group', 'subclinical keratoconus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tiajin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Yan Wang, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}