Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-29 @ 3:07 PM
Study NCT ID:
NCT05372861
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2022-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanopore Sequencing in Ophthalmology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Vitreous and aqueous humor samples in eyes with endophthalmitis gathered during vitrectomy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathogen detection', 'timeFrame': 'In vitro analysis after vitrectomy for endophthalmitis. Start of analysis: Within the next working day after sample acquisition. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.', 'description': 'Pathogens detected by Nanopore sequencing versus microbiologic culture'}], 'secondaryOutcomes': [{'measure': 'Time to pathogen detection', 'timeFrame': 'Time measured from start of analysis until arrival of results. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.', 'description': 'Time in days from gathering of the sample until arrival of results'}, {'measure': 'Visual acuity', 'timeFrame': 'Gathered from patient charts two months after vitrectomy.', 'description': 'Visual acuity measured with Snellen charts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endophthalmitis', 'Nanopore sequencing', 'Next Generation Sequencing'], 'conditions': ['Endophthalmitis']}, 'descriptionModule': {'briefSummary': 'In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.', 'detailedDescription': 'Vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. The gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the MinION Mk1b, a commercially available device for DNA/RNA sequencing. Base reads from Nanopore sequencing are then compared with available libraries for pathogen identification. The Nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. Clinical features and visual function before and after vitrectomy are gathered from patient charts. Treatment is not altered due to results of the Nanopore sequencing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eyes of adult patients with endophthalmitis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes of patients with endophthalmitis\n\nExclusion Criteria:\n\n* No informed consent possible\n* Participation in other studies'}, 'identificationModule': {'nctId': 'NCT05372861', 'briefTitle': 'Nanopore Sequencing in Ophthalmology', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Nanopore Sequencing in Ophthalmology - a Paradigm Shift in Pathogen Determination?', 'orgStudyIdInfo': {'id': 'NSIO'}}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Michael Sommer, MD', 'role': 'CONTACT', 'email': 'michael.sommer@medunigraz.at', 'phone': '004331638531033'}, {'name': 'Gerald Seidel, MD, PhD', 'role': 'CONTACT', 'email': 'gerald.seidel@medunigraz.at', 'phone': '004331638580714'}], 'facility': 'Universitäts Augenklinik Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Michael Sommer, MD', 'role': 'CONTACT', 'email': 'michael.sommer@medunigraz.at', 'phone': '004331638531033'}, {'name': 'Gerald Seidel, MD, PhD', 'role': 'CONTACT', 'email': 'gerald.seidel@medunigraz.at', 'phone': '004331638580714'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}