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Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery

Primary Purpose

Eyelid Diseases, Ptosis, Eyelid, Blepharoptosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine follow-up
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Eyelid Diseases focused on measuring Oculoplastic, Eye plastic, Eyelid surgery, Telemedicine, Remote follow-up, Remote visit, Blepharoplasty, Ptosis repair, External levator resection, Internal levator resection, Ectropion repair, Entropion repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine

Routine

Arm Description

Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.

Patient in the routine arm will have their post-operative week one visit in clinic.

Outcomes

Primary Outcome Measures

FACE-Q 'Satisfaction with Outcome'
A patient-reported outcome measure assessing satisfaction with the surgical outcome.

Secondary Outcome Measures

FACE-Q 'Early Life Impact'
A patient-reported outcome measure assessing early life impact of facial plastic surgery.
FACE-Q 'Satisfaction with Doctor'
A patient-reported outcome measure assessing satisfaction with the surgeon.
Late post-operative complications
Investigator-reported post-operative complications.
Time burden
Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.

Full Information

First Posted
January 16, 2020
Last Updated
November 2, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04235803
Brief Title
Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Official Title
Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases, Ptosis, Eyelid, Blepharoptosis, Dermatochalasis, Ectropion, Entropion, Eyelid Tumor, Skin Cancer, Eyelid, Floppy Eyelid Syndrome
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
Arm Title
Routine
Arm Type
No Intervention
Arm Description
Patient in the routine arm will have their post-operative week one visit in clinic.
Intervention Type
Other
Intervention Name(s)
Telemedicine follow-up
Intervention Description
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
Primary Outcome Measure Information:
Title
FACE-Q 'Satisfaction with Outcome'
Description
A patient-reported outcome measure assessing satisfaction with the surgical outcome.
Time Frame
Approximately 3 months post-operatively
Secondary Outcome Measure Information:
Title
FACE-Q 'Early Life Impact'
Description
A patient-reported outcome measure assessing early life impact of facial plastic surgery.
Time Frame
Approximately 1 week post-operatively
Title
FACE-Q 'Satisfaction with Doctor'
Description
A patient-reported outcome measure assessing satisfaction with the surgeon.
Time Frame
Approximately 3 months post-operatively
Title
Late post-operative complications
Description
Investigator-reported post-operative complications.
Time Frame
Between the first and second post-operative visits (approximately 1 week to 3 months)
Title
Time burden
Description
Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.
Time Frame
Approximately 1 week post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davin C Ashraf, MD
Phone
415-353-2800
Email
davin.ashraf@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davin C Ashraf, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davin C Ashraf, MD
Phone
415-353-2800
Email
davin.ashraf@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Davin C Ashraf, MD
First Name & Middle Initial & Last Name & Degree
M Reza Vagefi, MD
First Name & Middle Initial & Last Name & Degree
Robert C Kersten, MD
First Name & Middle Initial & Last Name & Degree
Bryan J Winn, MD
First Name & Middle Initial & Last Name & Degree
Seanna Grob, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only plan to share in the event that journal requests de-identified data to be released.
Citations:
PubMed Identifier
28328635
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
29963556
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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. Erratum In: Plast Reconstr Surg. 2015 May;135(5):1507.
Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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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.
Results Reference
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Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery

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