Clinical trial NCT04235803: Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Official title: Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: FACE-Q 'Satisfaction with Outcome'
timeFrame: Approximately 3 months post-operatively
Secondary outcomes:
measure: FACE-Q 'Early Life Impact'
timeFrame: Approximately 1 week post-operatively
measure: FACE-Q 'Satisfaction with Doctor'
timeFrame: Approximately 3 months post-operatively
measure: Late post-operative complications
timeFrame: Between the first and second post-operative visits (approximately 1 week to 3 months)
measure: Time burden
timeFrame: Approximately 1 week post-operatively
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Davin C Ashraf, MD
role: PRINCIPAL_INVESTIGATOR
References:
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