Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235803
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Eyelid Diseases Ptosis, Eyelid Blepharoptosis Dermatochalasis Ectropion Entropion Eyelid Tumor Skin Cancer, Eyelid Floppy Eyelid Syndrome Other: Telemedicine follow-up Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to telemedicine follow-up versus routine in-person follow-up for the 1 week assessment after low-risk oculoplastic surgery.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telemedicine
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
Other: Telemedicine follow-up
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.

No Intervention: Routine
Patient in the routine arm will have their post-operative week one visit in clinic.



Primary Outcome Measures :
  1. FACE-Q 'Satisfaction with Outcome' [ Time Frame: Approximately 3 months post-operatively ]
    A patient-reported outcome measure assessing satisfaction with the surgical outcome.


Secondary Outcome Measures :
  1. FACE-Q 'Early Life Impact' [ Time Frame: Approximately 1 week post-operatively ]
    A patient-reported outcome measure assessing early life impact of facial plastic surgery.

  2. FACE-Q 'Satisfaction with Doctor' [ Time Frame: Approximately 3 months post-operatively ]
    A patient-reported outcome measure assessing satisfaction with the surgeon.

  3. Late post-operative complications [ Time Frame: Between the first and second post-operative visits (approximately 1 week to 3 months) ]
    Investigator-reported post-operative complications.

  4. Time burden [ Time Frame: Approximately 1 week post-operatively ]
    Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235803


Contacts
Layout table for location contacts
Contact: Davin C Ashraf, MD 415-353-2800 davin.ashraf@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Davin C Ashraf, MD    415-353-2800    davin.ashraf@ucsf.edu   
Principal Investigator: Davin C Ashraf, MD         
Sub-Investigator: M Reza Vagefi, MD         
Sub-Investigator: Robert C Kersten, MD         
Sub-Investigator: Bryan J Winn, MD         
Sub-Investigator: Seanna Grob, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Davin C Ashraf, MD University of California, San Francisco
Publications:

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04235803    
Other Study ID Numbers: Eye plastic telemedicine
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only plan to share in the event that journal requests de-identified data to be released.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Oculoplastic
Eye plastic
Eyelid surgery
Telemedicine
Remote follow-up
Remote visit
Blepharoplasty
Ptosis repair
External levator resection
Internal levator resection
Ectropion repair
Entropion repair
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Eyelid Neoplasms
Blepharoptosis
Eyelid Diseases
Entropion
Ectropion
Cutis Laxa
Neoplasms by Site
Neoplasms
Skin Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Facial Neoplasms
Head and Neck Neoplasms
Eye Neoplasms