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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Unknown

Conditions

Dermatochalasis
Ptosis, Eyelid
Skin Cancer, Eyelid
Blepharoptosis
Floppy Eyelid Syndrome
Ectropion
Entropion
Eyelid Diseases
Eyelid Tumor

Treatments

Other: Telemedicine follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT04235803
Eye plastic telemedicine

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Telemedicine
Experimental group
Description:
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
Treatment:
Other: Telemedicine follow-up
Routine
No Intervention group
Description:
Patient in the routine arm will have their post-operative week one visit in clinic.

Trial contacts and locations

1

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Central trial contact

Davin C Ashraf, MD

Data sourced from clinicaltrials.gov

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