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

Not Applicable

• Conditions: Eyelid Diseases; Ptosis, Eyelid; Entropion; Eyelid Tumor; Dermatochalasis; Blepharoptosis; Ectropion; Skin Cancer, Eyelid; Floppy Eyelid Syndrome
• Interventions: Other: Telemedicine follow-up

• Registration Number: NCT04235803
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Study Start: 2021-07-01
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	Telemedicine follow-up	Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.

Primary Outcome Measures

Name	Time	Method
FACE-Q 'Satisfaction with Outcome'	Approximately 3 months post-operatively	A patient-reported outcome measure assessing satisfaction with the surgical outcome.

Secondary Outcome Measures

Name	Time	Method
FACE-Q 'Early Life Impact'	Approximately 1 week post-operatively	A patient-reported outcome measure assessing early life impact of facial plastic surgery.
FACE-Q 'Satisfaction with Doctor'	Approximately 3 months post-operatively	A patient-reported outcome measure assessing satisfaction with the surgeon.
Late post-operative complications	Between the first and second post-operative visits (approximately 1 week to 3 months)	Investigator-reported post-operative complications.
Time burden	Approximately 1 week post-operatively	Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States