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OpenTrials
Completed

NCT Number: NCT04235803

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine follow-up

Other

A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.

Primary outcomes

  1. 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

  1. FACE-Q 'Early Life Impact'

    Time frame: Approximately 1 week post-operatively

    A patient-reported outcome measure assessing early life impact of facial plastic surgery.

  2. FACE-Q 'Satisfaction with Doctor'

    Time frame: Approximately 3 months post-operatively

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

  3. Late post-operative complications

    Time frame: Between the first and second post-operative visits (approximately 1 week to 3 months)

    Investigator-reported post-operative complications.

  4. Time burden

    Time frame: Approximately 1 week post-operatively

    Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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