NCT03947723

Histology Evaluation of Radiofrequency Ablation

Withdrawn NA Last updated 25 April 2023

What this trial tests

NA trial testing Radiofrequency ablation in Trichiasis. Withdrawn.

Timeline

2 July 2019

Primary endpoint
22 June 2020

22 June 2020

Quick facts

Lead sponsor	Ochsner Health System
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	single
Primary purpose	other
Start date	2 July 2019
Primary completion	22 June 2020
Estimated completion	22 June 2020

Drugs / interventions tested

• Radiofrequency ablation

Conditions studied

• Trichiasis — all drugs for Trichiasis →

Sponsor

Ochsner Health System — full company profile →

Who can join

18 and older, any sex, with Trichiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.