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

NCT04235803 | Unknown DMC

• 1 other identifier: Eye plastic telemedicine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• FACE-Q 'Satisfaction with Outcome'

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

  Approximately 3 months post-operatively

Secondary Outcomes (4)

• FACE-Q 'Early Life Impact'

  Approximately 1 week post-operatively

• FACE-Q 'Satisfaction with Doctor'

  Approximately 3 months post-operatively

• Late post-operative complications

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

• Time burden

  Approximately 1 week post-operatively

Study Arms (2)

Telemedicine

EXPERIMENTAL

Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.

Other: Telemedicine follow-up

Routine

NO INTERVENTION

Patient in the routine arm will have their post-operative week one visit in clinic.

Interventions

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.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (10)

• Vyas KS, Hambrick HR, Shakir A, Morrison SD, Tran DC, Pearson K, Vasconez HC, Mardini S, Gosman AA, Dobke M, Granick MS. A Systematic Review of the Use of Telemedicine in Plastic and Reconstructive Surgery and Dermatology. Ann Plast Surg. 2017 Jun;78(6):736-768. doi: 10.1097/SAP.0000000000001044.

  PMID: 28328635 BACKGROUND

• Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.

  PMID: 23842982 BACKGROUND

• Kummerow Broman K, Roumie CL, Stewart MK, Castellanos JA, Tarpley JL, Dittus RS, Pierce RA. Implementation of a Telephone Postoperative Clinic in an Integrated Health System. J Am Coll Surg. 2016 Oct;223(4):644-51. doi: 10.1016/j.jamcollsurg.2016.07.010. Epub 2016 Aug 18.

  PMID: 27545100 BACKGROUND

• Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2.

  PMID: 20679407 BACKGROUND

• Williams AM, Bhatti UF, Alam HB, Nikolian VC. The role of telemedicine in postoperative care. Mhealth. 2018 May 2;4:11. doi: 10.21037/mhealth.2018.04.03. eCollection 2018.

  PMID: 29963556 BACKGROUND

• Carter SR, Stewart JM, Khan J, Archer KF, Holds JB, Seiff SR, Dailey RA. Infection after blepharoplasty with and without carbon dioxide laser resurfacing. Ophthalmology. 2003 Jul;110(7):1430-2. doi: 10.1016/S0161-6420(03)00447-0.

  PMID: 12867404 BACKGROUND

• Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.

  PMID: 22186506 BACKGROUND

• Lee EW, Holtebeck AC, Harrison AR. Infection rates in outpatient eyelid surgery. Ophthalmic Plast Reconstr Surg. 2009 Mar-Apr;25(2):109-10. doi: 10.1097/IOP.0b013e3181994124.

  PMID: 19300151 BACKGROUND

• Mejia JD, Egro FM, Nahai F. Visual loss after blepharoplasty: incidence, management, and preventive measures. Aesthet Surg J. 2011 Jan;31(1):21-9. doi: 10.1177/1090820X10391212.

  PMID: 21239669 BACKGROUND

• Kam KY, Cole CJ, Bunce C, Watson MP, Kamal D, Olver JM. The lateral tarsal strip in ectropion surgery: is it effective when performed in isolation? Eye (Lond). 2012 Jun;26(6):827-32. doi: 10.1038/eye.2012.34. Epub 2012 Mar 9.

  PMID: 22402697 BACKGROUND

MeSH Terms

Conditions

Eyelid Diseases; Blepharoptosis; Cutis Laxa; Ectropion; Entropion; Eyelid Neoplasms

Condition Hierarchy (Ancestors)

Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Facial Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Eye Neoplasms

Study Officials

• Davin C Ashraf, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davin C Ashraf, MD

CONTACT

415-353-2800; davin.ashraf@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)