- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235803
Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Davin C Ashraf, MD
- Phone Number: 415-353-2800
- Email: davin.ashraf@ucsf.edu
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Contact:
- Davin C Ashraf, MD
- Phone Number: 415-353-2800
- Email: davin.ashraf@ucsf.edu
-
Principal Investigator:
- Davin C Ashraf, MD
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Sub-Investigator:
- M Reza Vagefi, MD
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Sub-Investigator:
- Robert C Kersten, MD
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Sub-Investigator:
- Bryan J Winn, MD
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Sub-Investigator:
- Seanna Grob, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are age 18 years or older
- Are fluent in English
- Own or have ready access to a smart phone, tablet, or personal computer with high speed internet
- Participate in an informed consent process with the surgeon(s) including documentation of written informed consent
Are undergoing a low-risk* eyelid procedure in a clinic, ambulatory surgery center, or hospital operating room setting, including but not limited to:
- upper eyelid blepharoplasty repair
- ectropion repair
- entropion repair
- external levator resection
- internal levator resection
- eyelid lesion removal and/or biopsy
- eyelid reconstruction and defect repair including after Mohs' surgery
- eyelid tightening procedures for Floppy Eyelid Syndrome
- tarsorrhaphy
- dacryocystorhinostomy
(*)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.
Exclusion Criteria:
- Are under the age of 18 years
- Are incarcerated
- 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)
- Are not fluent in English
- Do not have access to or do not feel comfortable using a smart phone, tablet, or personal computer
- Lack personal capacity for consent (i.e. those patients requiring consent for the surgery by a legal representative are excluded)
- Experience a serious intra-operative complication (this criterion is assessed after initial consent)
Are undergoing eyelid or other oculoplastic procedures that are deemed greater than low-risk for serious complications, including but not limited to:
- orbital surgery
- lower eyelid blepharoplasty
- repair of extensive eyelid defects following Mohs' surgery (roughly >33%)
- procedures requiring skin grafting
- procedures requiring extensive tissue rearrangement
- procedures involving an implant (e.g. frontalis sling, gold weight implantation; except dacryocystorhinostomy due to the low-risk nature of the lacrimal stent)
- procedures requiring in-person care at the first post-operative week (e.g. suture removal, bolster removal, patch removal)
Notably, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telemedicine
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
|
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
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No Intervention: Routine
Patient in the routine arm will have their post-operative week one visit in clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FACE-Q 'Satisfaction with Outcome'
Time Frame: Approximately 3 months post-operatively
|
A patient-reported outcome measure assessing satisfaction with the surgical outcome.
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Approximately 3 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FACE-Q 'Early Life Impact'
Time Frame: Approximately 1 week post-operatively
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A patient-reported outcome measure assessing early life impact of facial plastic surgery.
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Approximately 1 week post-operatively
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FACE-Q 'Satisfaction with Doctor'
Time Frame: Approximately 3 months post-operatively
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A patient-reported outcome measure assessing satisfaction with the surgeon.
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Approximately 3 months post-operatively
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Late post-operative complications
Time Frame: Between the first and second post-operative visits (approximately 1 week to 3 months)
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Investigator-reported post-operative complications.
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Between the first and second post-operative visits (approximately 1 week to 3 months)
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Time burden
Time Frame: Approximately 1 week post-operatively
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Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.
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Approximately 1 week post-operatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Davin C Ashraf, MD, University of California, San Francisco
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Plast Reconstr Surg. 2015 May;135(5):1507.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Aesthet Surg J. 2011 Mar 1;31(3):362. Ergo, Francesco Maria [corrected to Egro, Francesco Maria].
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eye plastic telemedicine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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