Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-04-23 @ 3:06 AM
Study NCT ID:
NCT02138266
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055954', 'term': 'Corneal Endothelial Cell Loss'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal endothelial cell density', 'timeFrame': 'Single time point - 1 day'}, {'measure': 'Coefficient of variation of endothelial cell area', 'timeFrame': 'Single time point - 1 day'}, {'measure': 'Corneal endothelial cell % hexagonality', 'timeFrame': 'Single time point - 1 day'}, {'measure': 'Central corneal thickness', 'timeFrame': 'Single time point - 1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Corneal Endothelial Cell Loss']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ophthalmology Practice', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):\n\n* Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;\n* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;\n* Subjects who agree to participate in the study.\n\nInclusion Criteria -Pathologic Adults (29-80 years old)\n\n* Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;\n* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;\n* Subjects who agree to participate in the study;\n* At least one eye with any of the following conditions:\n\n * History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy;\n * History of corneal transplant;\n * Physical injury or trauma to the cornea;\n * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies)\n * Keratoconus;\n * Long term PMMA contact lens use (greater than 3 years).\n\nExclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)\n\n* History of corneal transplant;\n* Long term Fuch's dystrophy (and other corneal endothelial dystrophies);\n* Keratoconus;\n* Guttata;\n* Diabetes mellitus type I or type II;\n* History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;\n* All contact lens wearers;\n* Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.\n\nExclusion Criteria -Pathologic Adults (29-80 years old):\n\n* Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye."}, 'identificationModule': {'nctId': 'NCT02138266', 'briefTitle': 'Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness', 'orgStudyIdInfo': {'id': 'TOPCON-SP-1P-US-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Pathologic Adults age 18-28 yrs', 'description': 'Non-Pathologic Adults age 18-28 yrs', 'interventionNames': ['Device: Topcon Specular Microscope SP-1P', 'Device: Konan Specular Microscope CELLCHEK XL']}, {'label': 'Non-Pathologic Adults age 29-80 yrs', 'description': 'Non-Pathologic Adults age 29-80 yrs', 'interventionNames': ['Device: Topcon Specular Microscope SP-1P', 'Device: Konan Specular Microscope CELLCHEK XL']}, {'label': 'Pathologic Adults age 29-80 yrs', 'description': 'Pathologic Adults age 29-80 yrs', 'interventionNames': ['Device: Topcon Specular Microscope SP-1P', 'Device: Konan Specular Microscope CELLCHEK XL']}], 'interventions': [{'name': 'Topcon Specular Microscope SP-1P', 'type': 'DEVICE', 'armGroupLabels': ['Non-Pathologic Adults age 18-28 yrs', 'Non-Pathologic Adults age 29-80 yrs', 'Pathologic Adults age 29-80 yrs']}, {'name': 'Konan Specular Microscope CELLCHEK XL', 'type': 'DEVICE', 'armGroupLabels': ['Non-Pathologic Adults age 18-28 yrs', 'Non-Pathologic Adults age 29-80 yrs', 'Pathologic Adults age 29-80 yrs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}