Histology Evaluation of Radiofrequency Ablation

NCT03947723 | Withdrawn FDA Device

• 2 other identifiers: STUDY00000551LSU IRB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trichiasis

Keywords

trichiasis; radiofrequency ablation; epilation; histology

Outcome Measures

Primary Outcomes (2)

• Extent of tissue damage

  The extent of damage will be measured on the tissue sections. The diameter of abnormal/damaged tissue will be measured in microns.

  Through study completion, approximately 6 months

• Severity of tissue damage

  The severity will be graded on a scale from 0 to 3, with 0 being no tissue changes and going up to 3 which will represent severe tissue changes.

  Through study completion, approximately 6 months

Study Arms (4)

Low power

EXPERIMENTAL

These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of "low."

Device: Radiofrequency ablation

1 power

EXPERIMENTAL

These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1.

Device: Radiofrequency ablation

1.5 power

EXPERIMENTAL

These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1.5

Device: Radiofrequency ablation

2 power

EXPERIMENTAL

These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 2.

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

The eyelid segments to be excised as part of their planned lateral tarsal strip procedure will be marked and divided into 4 equal sections (2 sections on each lid). A corneal shield will be placed into the fornix prior to treatment. Each section will be treated with the designated power setting in the following manner. The probe will be inserted into the follicle under direct visualization to a depth of approximately 1.4 mm. The designated power will be applied for 1 second. All lashes in each segment will be treated. The segments will then be excised and placed into labelled and coded containers of formalin.

1 power; 1.5 power; 2 power; Low power

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ochsner Health System: lead

Related Publications (3)

• Nakamoto, D., Bernardino, C.R. The Annoying Lash in the Eye: A Review of Trichiasis. Review of Ophthalmology. Retrieved from: https://www.reviewofophthalmology.com/article/the-annoying-lash-in-the-eye-a-review-of-trichiasis. 2007.

  BACKGROUND

• Kim GN, Yoo WS, Kim SJ, Han YS, Chung IY, Park JM, Yoo JM, Seo SW. The effect of 0.02% mitomycin C injection into the hair follicle with radiofrequency ablation in trichiasis patients. Korean J Ophthalmol. 2014 Feb;28(1):12-8. doi: 10.3341/kjo.2014.28.1.12. Epub 2014 Jan 21.

  PMID: 24505196 BACKGROUND

• Kezirian GM. Treatment of localized trichiasis with radiosurgery. Ophthalmic Plast Reconstr Surg. 1993 Dec;9(4):260-6. doi: 10.1097/00002341-199312000-00006.

  PMID: 8305373 BACKGROUND

MeSH Terms

Conditions

Trichiasis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Priya Sahu, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

• Jayne Weiss, MD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person examining the slides will be blinded to the power setting used.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a modified factorial trial. The tissue from all patients will be divided into 4 sections and undergo radiofrequency ablation at different settings in each section, giving us 4 groups. These 4 groups will be compared to each other.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 13, 2019
• Study Start: July 2, 2019
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share