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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
- FACE-Q 'Satisfaction with Outcome' [ Time Frame: Approximately 3 months post-operatively ]A patient-reported outcome measure assessing satisfaction with the surgical outcome.
- 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.
- FACE-Q 'Satisfaction with Doctor' [ Time Frame: Approximately 3 months post-operatively ]A patient-reported outcome measure assessing satisfaction with the surgeon.
- 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.
- 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.
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
|Contact: Davin C Ashraf, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Contact: Davin C Ashraf, MD 415-353-2800 email@example.com|
|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|
|Principal Investigator:||Davin C Ashraf, MD||University of California, San Francisco|