Blepharoptosis, Dermatochalasis, Ectropion, Entropion, Eyelid Diseases, Eyelid Tumor, Floppy Eyelid Syndrome, Ptosis, Eyelid, Skin Cancer, Eyelid
Conditions
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
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.
Interventions
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACE-Q 'Satisfaction with Outcome' | Approximately 3 months post-operatively | A patient-reported outcome measure assessing satisfaction with the surgical outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavin C Ashraf, MD
University of California, San Francisco
Outcome results
None listed