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Clinical Trials/NCT04235803
NCT04235803
Unknown
Not Applicable

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

University of California, San Francisco1 site in 1 country100 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eyelid Diseases
Sponsor
University of California, San Francisco
Enrollment
100
Locations
1
Primary Endpoint
FACE-Q 'Satisfaction with Outcome'
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
July 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

FACE-Q 'Satisfaction with Outcome'

Time Frame: Approximately 3 months post-operatively

A patient-reported outcome measure assessing satisfaction with the surgical outcome.

Secondary Outcomes

  • FACE-Q 'Early Life Impact'(Approximately 1 week post-operatively)
  • FACE-Q 'Satisfaction with Doctor'(Approximately 3 months post-operatively)
  • Late post-operative complications(Between the first and second post-operative visits (approximately 1 week to 3 months))
  • Time burden(Approximately 1 week post-operatively)

Study Sites (1)

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