WithdrawnNot Applicable

Histology Evaluation of Radiofrequency Ablation

Stopped: PI Left Institution

0Started 2019-07-02

Plain-language summary

Trichiasis is a disorder of misdirected eyelashes in which the lashes grow inward towards the eye. Trichiasis can occur as a result of chronic inflammation, infection, such as in herpes or trachoma, trauma, or rare diseases like ocular cicatricial pemphigoid or Stevens-Johnson syndrome. Trichiasis can result significant pain and corneal compromise, ranging from punctate erosions to frank abrasions, as the lashes constantly contact and irritate the ocular surface. Several treatment modalities are available, including mechanical epilation, electroepilation, cryotherapy, laser therapy, and surgical procedures to redirect the lashes. Radiofrequency ablation is a type of electroepilation that utilizes radiowaves to heat and destroy hair follicles. A fine needle is inserted into the follicle and current is applied to destroy the follicle. The needle allows the energy to be focused into the follicle and limits scarring of the surrounding tissues, and the follicles are in theory permanently destroyed in this procedure. Success rates are variable however, ranging from 56 to 90%. Currently, there is no standardized protocol for performing radiofrequency ablation. Many practitioners choose their power settings based on experience, and the Ellman Surgitron machine, a commonly used radiofrequency unit, actually states in their instructions that the power should be titrated based on user experience. In the literature, settings anywhere from 1 to 3 are seen. In this study, our purpose is to examine the effects of different power settings in radiofrequency at the histologic level. The investigators plan to test different power settings on eyelid tissue that would be normally excised and discarded during eyelid correction surgeries. The investigators hope to determine if there is an ideal power setting to achieve hair follicle destruction while minimizing surrounding tissue damage, which could then be used as the standard power setting for radiofrequency ablation of trichiatic lashes in clinical practice. The investigators hypothesize that as power increases, the extent and severity of tissue damage will increase.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Undergoing the bilateral tarsal strip procedure * The procedure requires at least 5 mm of tissue to be excised from each side to provide adequate tightening of the lower eyelids (to be determined intra-operatively) * Caucasian (to control for any different responses ellicited by the treatment in pigmented skin) Exclusion Criteria: * previous treatments for trichiasis along the lateral lower eyelid * madarosis of eyelashes * hypertrichosis of eyelashes * patients undergoing only unilateral tarsal strip procedures * history of eyelid trauma or chemical burns * patients with a history of disorders affecting the mucus membranes (ie: Stevens-Johnson syndrome, ocular cicatricial pemphigoid) * history of eyelid surgery * history of facial skin cancers * patients with eyelid lesions affecting the lateral lower eyelids * patients with active inflammatory ocular diseases (keratitis, scleritis, conjunctivitis, etc). These exclusion criteria are to generally encompass and exclude any eyelid or eyelash pathology that may confuse what histology changes are from the study treatments versus what pathology was already there at baseline.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Extent of tissue damage

Timeframe: Through study completion, approximately 6 months

Severity of tissue damage

Timeframe: Through study completion, approximately 6 months

Trial details

NCT IDNCT03947723

SponsorOchsner Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-22

View on ClinicalTrials.gov More Trichiasis trials