Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT04235803
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04235803
Study Brief:
Protocol Section:
NCT04235803