Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-05 @ 5:57 PM
Study NCT ID:
NCT03037268
Status:
WITHDRAWN
Last Update Posted:
2019-11-13
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Device is no longer available', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-09', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)'}, {'measure': 'Detection rate of "critical" retinal findings', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity (%) of detection of "critical" retinal findings with plenoptic ophthalmoscopy. Critical retinal findings include retinal detachment, retinal vascular sheathing, retinal hemorrhage, retinal whitening, optic disc edema, optic disc pallor, optic disc cupping (\\> 0.5 cup-to disc ratio)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retinal Imaging']}, 'referencesModule': {'references': [{'pmid': '22218140', 'type': 'BACKGROUND', 'citation': 'Lamirel C, Bruce BB, Wright DW, Delaney KP, Newman NJ, Biousse V. Quality of nonmydriatic digital fundus photography obtained by nurse practitioners in the emergency department: the FOTO-ED study. Ophthalmology. 2012 Mar;119(3):617-24. doi: 10.1016/j.ophtha.2011.09.013. Epub 2012 Jan 3.'}, {'pmid': '21268749', 'type': 'BACKGROUND', 'citation': 'Bruce BB, Lamirel C, Wright DW, Ward A, Heilpern KL, Biousse V, Newman NJ. Nonmydriatic ocular fundus photography in the emergency department. N Engl J Med. 2011 Jan 27;364(4):387-9. doi: 10.1056/NEJMc1009733. No abstract available.'}, {'pmid': '27842198', 'type': 'BACKGROUND', 'citation': 'Adam MK, Aenchbacher W, Kurzweg T, Hsu J. Plenoptic Ophthalmoscopy: A Novel Imaging Technique. Ophthalmic Surg Lasers Imaging Retina. 2016 Nov 1;47(11):1038-1043. doi: 10.3928/23258160-20161031-08.'}]}, 'descriptionModule': {'briefSummary': "1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department (FOTO-ED) Study.\n2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked image reviewers' quality measurements and findings to images obtained with a commercially available ocular fundus camera and documented exam findings", 'detailedDescription': 'Visualization of the ocular fundus is considered an essential part of the physical examination, as abnormalities of the optic nerve, retinal vessels, and macula can reveal underlying systemic diseases and explain the etiology of visual complaints.\n\nThe Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department (FOTO-ED) Study demonstrated that only 14% of patients with complaints and conditions in which fundus examination is considered important had direct ophthalmoscopy performed by an ED physician .Greater than 80% of previously unknown fundus findings relevant to ED patient management were missed by ED physicians, but were identified by nonmydriatic digital fundus photography. Several of these cases resulted in recall of a discharged patient back to the ED for hospital admission once diagnostic fundus photos were reviewed.\n\nIn the search for an alternative to improve ease of use and fundus image quality, plenoptic technology provides a promising option for portable fundus imaging. Plenoptic, or light field, imaging has recently been introduced commercially with the release of the Lytro Plenoptic Camera (Mountain View, CA, USA). Utilizing an array of microlenses, the Lytro camera captures all available light in a scene from multiple vectors. By dividing up a scene as a whole with many individual microlenses, images can be refocused in post processing after acquisition, sharp focus can be attained in low light situations, and stereo images with perspective shifting can be attained.\n\nTo date there have been no published quantitative descriptions of the quality and reliability of plenoptic ophthalmoscopy using a commercially available, portable light field camera. Initial work from a pilot study using animal and human eyes was published in 2016. The purpose of the proposed prospective, cross sectional imaging study is to compare standard mydriatic fundus photography to a second generation camera developed with a Lytro plenoptic camera and customized light source, specifically analyzing diagnostic utility/sensitivity of detecting retinal pathology and overall image quality. If the image quality outcomes of the investigators proposed study are similar to those of the nonmydriatic fundus camera, the implications for physicians and the potential applications to ophthalmology related telemedicine are significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With and without visually significant posterior retinal or optic nerve pathology,\n* Pregnant women if already dilated for reason other than study participation.\n\nExclusion Criteria:\n\n* Children,\n* Prisoners,\n* Poor view of posterior pole due to anterior segment pathology,\n* Poor view of posterior pole due to posterior media opacities that necessitate use of B-scan ultrasound to evaluate posterior pole.'}, 'identificationModule': {'nctId': 'NCT03037268', 'acronym': 'PORT', 'briefTitle': 'Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial', 'orgStudyIdInfo': {'id': '14-447E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing dilated examination', 'description': '* examined in the Retina Service of Wills Eye Hospital\n* with and without visually significant posterior retinal or optic nerve pathology\n* imaged with a Lytro Plenoptic Camera and 28D lens', 'interventionNames': ['Device: Lytro Plenoptic Camera and 28D lens']}], 'interventions': [{'name': 'Lytro Plenoptic Camera and 28D lens', 'type': 'DEVICE', 'description': '* visual acuity measured, intraocular pressure obtained, eyes dilated as part of a standard exam for intended patient visit\n* screened and consented for study\n* subjected to bilateral plenoptic ophthalmoscopy\n* mydriatic, single-field fundus images obtained\n* images reviewed for quality and diagnostic utility by a masked grader', 'armGroupLabels': ['Patients undergoing dilated examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina- Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jason Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mid Atlantic Retina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr., MD', 'investigatorFullName': 'Jason Hsu, MD', 'investigatorAffiliation': 'Wills Eye'}}}}