Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-01-16 @ 7:10 PM
Study NCT ID:
NCT02423161
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PIONEER: Intraoperative and Perioperative OCT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of intraoperative OCT', 'timeFrame': '3 years', 'description': 'Defined as percentage of cases where OCT was successfully able to be obtained during surgery'}], 'secondaryOutcomes': [{'measure': 'Utility of intraoperative OCT', 'timeFrame': '3 years', 'description': 'Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire'}, {'measure': 'Safety of intraoperative OCT', 'timeFrame': '3 years', 'description': 'Defined as the percentage of subjects that experience adverse events that were related to the intraoperative OCT and/or in excess of what might be expected relative to the surgery performed'}, {'measure': 'Time requirements for intraoperative OCT', 'timeFrame': '3 years', 'description': 'Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OCT', 'image-guided surgery', 'vitreoretinal surgery', 'corneal surgery'], 'conditions': ['Retinal Detachment', 'Epiretinal Membrane', 'Macular Hole', 'Fuchs Endothelial Dystrophy']}, 'referencesModule': {'references': [{'pmid': '23609120', 'type': 'BACKGROUND', 'citation': 'Ehlers JP, Ohr MP, Kaiser PK, Srivastava SK. Novel microarchitectural dynamics in rhegmatogenous retinal detachments identified with intraoperative optical coherence tomography. Retina. 2013 Jul-Aug;33(7):1428-34. doi: 10.1097/IAE.0b013e31828396b7.'}, {'pmid': '23860560', 'type': 'BACKGROUND', 'citation': 'Ehlers JP, Xu D, Kaiser PK, Singh RP, Srivastava SK. Intrasurgical dynamics of macular hole surgery: an assessment of surgery-induced ultrastructural alterations with intraoperative optical coherence tomography. Retina. 2014 Feb;34(2):213-21. doi: 10.1097/IAE.0b013e318297daf3.'}, {'pmid': '25525173', 'type': 'RESULT', 'citation': 'Ehlers JP, Itoh Y, Xu LT, Kaiser PK, Singh RP, Srivastava SK. Factors associated with persistent subfoveal fluid and complete macular hole closure in the PIONEER study. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(2):1141-6. doi: 10.1167/iovs.14-15765.'}, {'pmid': '25077834', 'type': 'RESULT', 'citation': 'Ehlers JP, Dupps WJ, Kaiser PK, Goshe J, Singh RP, Petkovsek D, Srivastava SK. The Prospective Intraoperative and Perioperative Ophthalmic ImagiNg with Optical CoherEncE TomogRaphy (PIONEER) Study: 2-year results. Am J Ophthalmol. 2014 Nov;158(5):999-1007. doi: 10.1016/j.ajo.2014.07.034. Epub 2014 Jul 29.'}, {'pmid': '25055146', 'type': 'RESULT', 'citation': 'Juthani VV, Goshe JM, Srivastava SK, Ehlers JP. Association between transient interface fluid on intraoperative OCT and textural interface opacity after DSAEK surgery in the PIONEER study. Cornea. 2014 Sep;33(9):887-92. doi: 10.1097/ICO.0000000000000209.'}, {'pmid': '26114817', 'type': 'DERIVED', 'citation': 'Au J, Goshe J, Dupps WJ Jr, Srivastava SK, Ehlers JP. Intraoperative Optical Coherence Tomography for Enhanced Depth Visualization in Deep Anterior Lamellar Keratoplasty From the PIONEER Study. Cornea. 2015 Sep;34(9):1039-43. doi: 10.1097/ICO.0000000000000508.'}]}, 'descriptionModule': {'briefSummary': 'OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.', 'detailedDescription': 'Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.\n\nDue to restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-top models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.\n\nUsing information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.\n\nA microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes any patient requiring ophthalmic surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population includes any patient requiring ophthalmic surgery\n\nExclusion Criteria:\n\n* Children under the age of 18\n* Cognitive/Mentally impaired or unable to provide consent\n* Media opacity precluding OCT scanning'}, 'identificationModule': {'nctId': 'NCT02423161', 'acronym': 'PIONEER', 'briefTitle': 'PIONEER: Intraoperative and Perioperative OCT Study', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study', 'orgStudyIdInfo': {'id': '11-787'}}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cole Eye Institute, Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Justis P Ehlers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cole Eye Institute, Cleveland Clinic, OH 44195'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Justis Ehlers', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}