Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 5:55 PM
Study NCT ID:
NCT04235803
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D001763', 'term': 'Blepharoptosis'}, {'id': 'D003483', 'term': 'Cutis Laxa'}, {'id': 'D004483', 'term': 'Ectropion'}, {'id': 'D004774', 'term': 'Entropion'}, {'id': 'D005142', 'term': 'Eyelid Neoplasms'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D005153', 'term': 'Facial Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "FACE-Q 'Satisfaction with Outcome'", 'timeFrame': 'Approximately 3 months post-operatively', 'description': 'A patient-reported outcome measure assessing satisfaction with the surgical outcome.'}], 'secondaryOutcomes': [{'measure': "FACE-Q 'Early Life Impact'", 'timeFrame': 'Approximately 1 week post-operatively', 'description': 'A patient-reported outcome measure assessing early life impact of facial plastic surgery.'}, {'measure': "FACE-Q 'Satisfaction with Doctor'", 'timeFrame': 'Approximately 3 months post-operatively', 'description': 'A patient-reported outcome measure assessing satisfaction with the surgeon.'}, {'measure': 'Late post-operative complications', 'timeFrame': 'Between the first and second post-operative visits (approximately 1 week to 3 months)', 'description': 'Investigator-reported post-operative complications.'}, {'measure': 'Time burden', 'timeFrame': 'Approximately 1 week post-operatively', 'description': 'Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oculoplastic', 'Eye plastic', 'Eyelid surgery', 'Telemedicine', 'Remote follow-up', 'Remote visit', 'Blepharoplasty', 'Ptosis repair', 'External levator resection', 'Internal levator resection', 'Ectropion repair', 'Entropion repair'], 'conditions': ['Eyelid Diseases', 'Ptosis, Eyelid', 'Blepharoptosis', 'Dermatochalasis', 'Ectropion', 'Entropion', 'Eyelid Tumor', 'Skin Cancer, Eyelid', 'Floppy Eyelid Syndrome']}, 'referencesModule': {'references': [{'pmid': '28328635', 'type': 'BACKGROUND', 'citation': 'Vyas KS, Hambrick HR, Shakir A, Morrison SD, Tran DC, Pearson K, Vasconez HC, Mardini S, Gosman AA, Dobke M, Granick MS. A Systematic Review of the Use of Telemedicine in Plastic and Reconstructive Surgery and Dermatology. Ann Plast Surg. 2017 Jun;78(6):736-768. doi: 10.1097/SAP.0000000000001044.'}, {'pmid': '23842982', 'type': 'BACKGROUND', 'citation': 'Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.'}, {'pmid': '27545100', 'type': 'BACKGROUND', 'citation': 'Kummerow Broman K, Roumie CL, Stewart MK, Castellanos JA, Tarpley JL, Dittus RS, Pierce RA. Implementation of a Telephone Postoperative Clinic in an Integrated Health System. J Am Coll Surg. 2016 Oct;223(4):644-51. doi: 10.1016/j.jamcollsurg.2016.07.010. Epub 2016 Aug 18.'}, {'pmid': '20679407', 'type': 'BACKGROUND', 'citation': 'Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2.'}, {'pmid': '29963556', 'type': 'BACKGROUND', 'citation': 'Williams AM, Bhatti UF, Alam HB, Nikolian VC. The role of telemedicine in postoperative care. Mhealth. 2018 May 2;4:11. doi: 10.21037/mhealth.2018.04.03. eCollection 2018.'}, {'pmid': '12867404', 'type': 'BACKGROUND', 'citation': 'Carter SR, Stewart JM, Khan J, Archer KF, Holds JB, Seiff SR, Dailey RA. Infection after blepharoplasty with and without carbon dioxide laser resurfacing. Ophthalmology. 2003 Jul;110(7):1430-2. doi: 10.1016/S0161-6420(03)00447-0.'}, {'pmid': '22186506', 'type': 'BACKGROUND', 'citation': 'Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.'}, {'pmid': '19300151', 'type': 'BACKGROUND', 'citation': 'Lee EW, Holtebeck AC, Harrison AR. Infection rates in outpatient eyelid surgery. Ophthalmic Plast Reconstr Surg. 2009 Mar-Apr;25(2):109-10. doi: 10.1097/IOP.0b013e3181994124.'}, {'pmid': '21239669', 'type': 'BACKGROUND', 'citation': 'Mejia JD, Egro FM, Nahai F. Visual loss after blepharoplasty: incidence, management, and preventive measures. Aesthet Surg J. 2011 Jan;31(1):21-9. doi: 10.1177/1090820X10391212.'}, {'pmid': '22402697', 'type': 'BACKGROUND', 'citation': 'Kam KY, Cole CJ, Bunce C, Watson MP, Kamal D, Olver JM. The lateral tarsal strip in ectropion surgery: is it effective when performed in isolation? Eye (Lond). 2012 Jun;26(6):827-32. doi: 10.1038/eye.2012.34. Epub 2012 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose utilizing a simple telemedical protocol to allow patients to substitute the first post-operative visit with a remote survey that includes essential post-operative history, vision measurement, and photographs, all of which can be provided using a personal computer, tablet, or smart phone. The investigators have selected for this purpose a subset of oculoplastic procedures involving the eyelid and lacrimal system that have well-reported low rates of serious complications, since high-risk procedures will likely always require close, in-person care. The investigators hypothesize that telemedicine follow-up for the first post-operative week after low-risk oculoplastic surgery will decrease the time burden on patients without compromising their satisfaction or increase the risk of late post-operative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are age 18 years or older\n* Are fluent in English\n* Own or have ready access to a smart phone, tablet, or personal computer with high speed internet\n* Participate in an informed consent process with the surgeon(s) including documentation of written informed consent\n* Are undergoing a low-risk\\* eyelid procedure in a clinic, ambulatory surgery center, or hospital operating room setting, including but not limited to:\n\n * upper eyelid blepharoplasty repair\n * ectropion repair\n * entropion repair\n * external levator resection\n * internal levator resection\n * eyelid lesion removal and/or biopsy\n * eyelid reconstruction and defect repair including after Mohs' surgery\n * eyelid tightening procedures for Floppy Eyelid Syndrome\n * tarsorrhaphy\n * dacryocystorhinostomy\n\n(\\*)These listed procedures have a low reported rate of serious complications including vision loss, infection, severe bleeding, or death; however, surgical risk is ultimately determined by the surgeon on a per-patient basis, except in those cases specifically excluded in the subsequent section.\n\nExclusion Criteria:\n\n* Are under the age of 18 years\n* Are incarcerated\n* Are pregnant or plan to become pregnant during the period of surgery and 3 month recovery (however these patients are not eligible for elective eyelid surgery)\n* Are not fluent in English\n* Do not have access to or do not feel comfortable using a smart phone, tablet, or personal computer\n* Lack personal capacity for consent (i.e. those patients requiring consent for the surgery by a legal representative are excluded)\n* Experience a serious intra-operative complication (this criterion is assessed after initial consent)\n* Are undergoing eyelid or other oculoplastic procedures that are deemed greater than low-risk for serious complications, including but not limited to:\n\n * orbital surgery\n * lower eyelid blepharoplasty\n * repair of extensive eyelid defects following Mohs' surgery (roughly \\>33%)\n * procedures requiring skin grafting\n * procedures requiring extensive tissue rearrangement\n * procedures involving an implant (e.g. frontalis sling, gold weight implantation; except dacryocystorhinostomy due to the low-risk nature of the lacrimal stent)\n * procedures requiring in-person care at the first post-operative week (e.g. suture removal, bolster removal, patch removal)\n\nNotably, patients undergoing greater than low risk procedures listed here are absolutely excluded from this trial. Surgeon assessment of individual patient surgical risk only applies to those typically low-risk procedures listed in the previous section on inclusion criteria; reasons for escalation of risk level include patient characteristics (e.g. frailty, previous infection or wound dehiscence), re-operation/revision status, or other factors."}, 'identificationModule': {'nctId': 'NCT04235803', 'briefTitle': 'Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery', 'orgStudyIdInfo': {'id': 'Eye plastic telemedicine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine', 'description': 'Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.', 'interventionNames': ['Other: Telemedicine follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Routine', 'description': 'Patient in the routine arm will have their post-operative week one visit in clinic.'}], 'interventions': [{'name': 'Telemedicine follow-up', 'type': 'OTHER', 'description': 'A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Davin C Ashraf, MD', 'role': 'CONTACT', 'email': 'davin.ashraf@ucsf.edu', 'phone': '415-353-2800'}, {'name': 'Davin C Ashraf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'M Reza Vagefi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert C Kersten, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bryan J Winn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seanna Grob, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Davin C Ashraf, MD', 'role': 'CONTACT', 'email': 'davin.ashraf@ucsf.edu', 'phone': '415-353-2800'}], 'overallOfficials': [{'name': 'Davin C Ashraf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only plan to share in the event that journal requests de-identified data to be released.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}