Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Davin C Ashraf

Description

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.

Keywords

Eyelid Diseases Ptosis, Eyelid Blepharoptosis Dermatochalasis Ectropion Entropion Eyelid Tumor Skin Cancer, Eyelid Floppy Eyelid Syndrome Oculoplastic Eye plastic Eyelid surgery Telemedicine Remote follow-up Remote visit Blepharoplasty Ptosis repair External levator resection Internal levator resection Ectropion repair Entropion repair Skin Neoplasms Eyelid Neoplasms Cutis Laxa Telemedicine follow-up Routine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04235803
Study Type
Interventional
Last Updated