Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-03-27 @ 6:28 PM
Study NCT ID:
NCT05416268
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Diopsys NOVA and LKC RETeval Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004596', 'term': 'Electroretinography'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study is an open label, prospective study comparing the Diopsys NOVA and LKC RETeval devices using the Diopsys Lid Electrodes and the LKC RETeval Self-Adhering Electrode Arrays.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PhNR B-wave Latency (ms)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR B-wave Latency (ms) parameter'}, {'measure': 'FL Magnitude (µV)', 'timeFrame': 'Day 1', 'description': 'Change in ERG FL Magnitude (µV) parameter'}, {'measure': 'PhNR A-Wave Latency (ms)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR A-Wave Latency (ms) parameter'}, {'measure': 'PhNR Ratio', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR Ratio parameter'}, {'measure': 'PhNR amplitude (µV)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR amplitude (µV) parameter'}, {'measure': 'PhNR B-Wave Amplitude (µV)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR B-Wave Amplitude (µV) parameter'}, {'measure': 'PhNR A-Wave Amplitude (µV)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR A-Wave Amplitude (µV) parameter'}, {'measure': 'FL Phase (deg)', 'timeFrame': 'Day 1', 'description': 'Change in ERG FL Phase (deg) parameter'}], 'primaryOutcomes': [{'measure': 'PhNR Latency (ms)', 'timeFrame': 'Day 1', 'description': 'Change in ERG PhNR Latency (ms) parameter'}], 'secondaryOutcomes': [{'measure': 'FL Latency (ms)', 'timeFrame': 'Day 1', 'description': 'Change in ERG FL Latency (ms) parameter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Retinal Disease']}, 'descriptionModule': {'briefSummary': 'To compare the Diopsys NOVA and LKC RETeval Devices using the Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays.', 'detailedDescription': 'This study is an open label, prospective study comparing the Diopsys NOVA and LKC RETeval devices using the Diopsys Lid Electrodes and the LKC RETeval Self-Adhering Electrode Arrays.\n\nSubjects will receive the PhNR test three times using the Diopsys device and Diopsys Electrodes. Next, subjects will receive the FL Flicker test three times using the Diopsys device and Diopsys Electrodes. There will be a short break (10 to 15 minutes), then subjects will receive the PhNR test three times using the Diopsys device with LKC Electrode Arrays, followed by the FL Flicker test three times using the Diopsys device with the LKC electrode arrays. Subjects will receive another short break (5 to 10 minutes), then receive the PhNR test three times using the LKC device with the LKC electrode arrays, followed by the FL Flicker test three times using the LKC device with the LKC electrode arrays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 22 years of age on day of enrollment\n* BCVA letter score of 75 or better (Snellen equivalent of 20/32 or better) on day of enrollment\n* Eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. Subject has not been diagnosed with any ocular pathology that could affect ERG results.\n* Able to communicate well with the Investigator and able to understand and comply with the requirements of the study\n* Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines\n\nExclusion Criteria:\n\n* A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D on day of enrollment\n* Intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment)\n* Any prior macular or panretinal photocoagulation laser treatment\n* History of ophthalmic or neurologic condition known to affect visual function\n* Inability to obtain a reliable ERG test\n* History of Diabetic retinopathy\n* History of Glaucoma\n* History of ARMD\n* History of seizure disorder\n* Has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays\n* In the opinion of the Investigator, is unlikely to comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT05416268', 'briefTitle': 'Study to Compare the Diopsys NOVA and LKC RETeval Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diopsys, Inc.'}, 'officialTitle': 'An Objective Study to Compare the Diopsys NOVA and LKC RETeval Devices Using the Diopsys LID Electrodes and the LKC RETeval Self-Adhering Electrode Arrays', 'orgStudyIdInfo': {'id': '200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Diopsys NOVA and Diopsys Electrodes', 'description': 'Subjects will receive the PhNR test three times using the Diopsys device and Diopsys Electrodes. Next, subjects will receive the FL Flicker test three times using the Diopsys device and Diopsys Electrodes.', 'interventionNames': ['Diagnostic Test: Electroretinography']}, {'type': 'OTHER', 'label': 'Diopsys device with LKC Electrode Arrays', 'description': 'Subjects will receive the PhNR test three times using the Diopsys device with LKC Electrode Arrays, followed by the FL Flicker test three times using the Diopsys device with the LKC electrode arrays.', 'interventionNames': ['Diagnostic Test: Electroretinography']}, {'type': 'OTHER', 'label': 'LKC device with the LKC electrode arrays', 'description': 'Subjects will receive the PhNR test three times using the LKC device with the LKC electrode arrays, followed by the FL Flicker test three times using the LKC device with the LKC electrode arrays.', 'interventionNames': ['Diagnostic Test: Electroretinography']}], 'interventions': [{'name': 'Electroretinography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Electrode Arrays'], 'description': 'Two different electroretinogram devices (Diopsys NOVA and LKC RETeval Devices) will be evaluated with two different electrode arrays (Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays).', 'armGroupLabels': ['Diopsys NOVA and Diopsys Electrodes', 'Diopsys device with LKC Electrode Arrays', 'LKC device with the LKC electrode arrays']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74464', 'city': 'Tahlequah', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'NSU Oklahoma College of Optometry', 'geoPoint': {'lat': 35.91537, 'lon': -94.96996}}], 'overallOfficials': [{'name': 'Nate Lighthizer, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NSU Oklahoma College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diopsys, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}