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Eyelid DiseasesNCT04235803

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

A study testing Telemedicine follow-up in people with Eyelid Diseases and Ptosis, Eyelid, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eyelid Diseases, Ptosis, Eyelid, Blepharoptosis
What is being tested?
Telemedicine follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 27 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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)
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Being tested
Telemedicine follow-up
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
Medical subject headings
Eyelid Diseases, Blepharoptosis, Cutis Laxa, Ectropion, Entropion, Eyelid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine follow-upOther

    A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.

Study groups in NCT04235803
Study groupRoleWhat they receive
TelemedicineExperimentalPatients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
Receives: Other: Telemedicine follow-up
RoutineNo interventionPatient in the routine arm will have their post-operative week one visit in clinic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FACE-Q 'Satisfaction with Outcome'

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

    Measured: Approximately 3 months post-operatively

Secondary outcomes (4)

  1. FACE-Q 'Early Life Impact'

    A patient-reported outcome measure assessing early life impact of facial plastic surgery.

    Measured: Approximately 1 week post-operatively

  2. FACE-Q 'Satisfaction with Doctor'

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

    Measured: Approximately 3 months post-operatively

  3. Late post-operative complications

    Investigator-reported post-operative complications.

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

  4. Time burden

    Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.

    Measured: Approximately 1 week post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start1 Sep 2020
  3. Primary completion27 Jul 2021
  4. Study completion27 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235803
Sponsor's protocol ID
Eye plastic telemedicine
Status last verified
Jul 2026
First submitted
16 Jan 2020
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only plan to share in the event that journal requests de-identified data to be released.

Publications

  • 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.

    PubMed 28328635

  • 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.

    PubMed 23842982

  • 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.

    PubMed 27545100

  • 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.

    PubMed 20679407

  • 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.

    PubMed 29963556

  • 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.

    PubMed 12867404

  • 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.

    PubMed 22186506

  • 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.

    PubMed 19300151

  • 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.

    PubMed 21239669

  • 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.

    PubMed 22402697

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine follow-up in people with Eyelid Diseases and Ptosis, Eyelid, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACE-Q 'Satisfaction with Outcome' (time frame: Approximately 3 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235803, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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