TrichiasisNCT03947723
Histology Evaluation of Radiofrequency Ablation
A study testing Radiofrequency ablation in people with Trichiasis, run by Ochsner Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trichiasis
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2019to 22 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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.
About this study
Official title: Histologic Evaluation Comparing Power Settings in Radiofrequency Ablation on Eyelash Follicles
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.
Read the detailed description
Subject fulfilling the inclusion and exclusion criteria and willing to participate in the study will be enrolled. All participants will receive all 4 treatments at the varying power settings (low, 1, 1.5, 2).
The patients will be prepped for their surgery in the usual fashion. This portion of the procedure is not experimental and is an elective surgery that the patients are choosing to undergo prior to enrolling in the study. This procedure is performed in the operating room. After adequate anesthesia is achieved, subcutaneous 2% lidocaine with epinephrine with 0.5% marcaine, and vitrase is injected into the lower eyelids and lateral canthal areas. The face is prepped and draped in sterile fashion using topical Betadine. A corneal shield will be placed into the fornix at this time. A lateral canthal incision is then made using a #15 blade. Straight Stevens scissors are used to perform a canthotomy and monopolar cautery was used to incise the inferior crus of the lateral canthal tendon. Hemostasis is maintained. The freed lower eyelid is draped over the zygoma. The excess eyelid is then excised full-thickness with Westcott scissors. (If this excess eyelid skin is at least 5 mm on both sides, the study will be performed and the treatments will be applied at this point). The tissue will be marked and divided into 4 equal sections (2 sections on each lid). 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.
Attention will then be directed back to completing the lateral tarsal strip/eyelid surgery. The remainder of the surgery will be performed in the usual fashion and is not part of the experimental portion of the study. One 4-0 Vicryl on P-2 needle is then passed through the tarsus backhanded anterior inferiorly exiting posterior superiorly within the wound and then passed back through the periosteum approximately 3 mm from the orbital rim at the level of the superior crus of the lateral canthal tendon and temporarily tied. This procedure is repeated in full on the other side. The sides are compared. Once the proper contour and tightness is achieved, the suture is permanently tied in a horizontal mattress fashion after passing back through the remnants of the inferior crus. Attention is then turned to the upper lid, whose lateral mucocutaneous junction is trimmed using Westcott scissors. The gray lines of the lateral upper and lower eyelids arre reapposed using 6-0 Vicryl. The lateral canthal incisions are closed with a running 6-0 Prolene suture. Tobradex ointment is applied to the eye and eyelid. The patient is awakened and extubated and taken to the recovery room in stable condition. The patients will be examined at their post-operative week 1 and month 1 visits as per the usual standard of care. After the 1 month visit, their participation in the study is complete.
The tissue sections will be sent to the pathology department for sectioning and staining. The tissue will be sectioned through the follicles. The slides will be stained with hemotoxylin and eosin and Masson-Trichrome. The extent of tissue damage will be measured as the diameter of abnormal/damaged tissue in microns. The severity will be graded on a numerical scale from 0-3. The results will be compared among the 4 power settings.
- Conditions
- Trichiasis
- Being tested
- Radiofrequency ablation
- Keywords
- trichiasis, radiofrequency ablation, epilation, histology
- Medical subject headings
- Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low power | Experimental | These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of "low." Receives: Device: Radiofrequency ablation |
| 1 power | Experimental | These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1. Receives: Device: Radiofrequency ablation |
| 1.5 power | Experimental | These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1.5 Receives: Device: Radiofrequency ablation |
| 2 power | Experimental | These tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 2. Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start2 Jul 2019
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Why it stopped: PI Left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TrichiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priya Sahu, MD, Principal investigator, Ochsner Health SystemJayne Weiss, MD, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947723
- Sponsor's protocol ID
- STUDY00000551
- Other IDs
- LSU IRB
- Status last verified
- Apr 2023
- First submitted
- 7 May 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share with other researchers
Publications
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.
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.
PubMed 24505196Kezirian GM. Treatment of localized trichiasis with radiosurgery. Ophthalmic Plast Reconstr Surg. 1993 Dec;9(4):260-6. doi: 10.1097/00002341-199312000-00006.
PubMed 8305373
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Evaluation Comparing Power Settings in Radiofrequency Ablation on Eyelash Follicles
- ClinicalTrials.gov ID
- NCT03947723
- Acronym / sponsor ID
- STUDY00000551
- Conditions
- Trichiasis
- Keywords
- trichiasis, radiofrequency ablation, epilation, histology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subject fulfilling the inclusion and exclusion criteria and willing to participate in the study will be enrolled. All participants will receive all 4 treatments at the varying power settings (low, 1, 1.5, 2).
The patients will be prepped for their surgery in the usual fashion. This portion of the procedure is not experimental and is an elective surgery that the patients are choosing to undergo prior to enrolling in the study. This procedure is performed in the operating room. After adequate anesthesia is achieved, subcutaneous 2% lidocaine with epinephrine with 0.5% marcaine, and vitrase is injected into the lower eyelids and lateral canthal areas. The face is prepped and draped in sterile fashion using topical Betadine. A corneal shield will be placed into the fornix at this time. A lateral canthal incision is then made using a #15 blade. Straight Stevens scissors are used to perform a canthotomy and monopolar cautery was used to incise the inferior crus of the lateral canthal tendon. Hemostasis is maintained. The freed lower eyelid is draped over the zygoma. The excess eyelid is then excised full-thickness with Westcott scissors. (If this excess eyelid skin is at least 5 mm on both sides, the study will be performed and the treatments will be applied at this point). The tissue will be marked and divided into 4 equal sections (2 sections on each lid). 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.
Attention will then be directed back to completing the lateral tarsal strip/eyelid surgery. The remainder of the surgery will be performed in the usual fashion and is not part of the experimental portion of the study. One 4-0 Vicryl on P-2 needle is then passed through the tarsus backhanded anterior inferiorly exiting posterior superiorly within the wound and then passed back through the periosteum approximately 3 mm from the orbital rim at the level of the superior crus of the lateral canthal tendon and temporarily tied. This procedure is repeated in full on the other side. The sides are compared. Once the proper contour and tightness is achieved, the suture is permanently tied in a horizontal mattress fashion after passing back through the remnants of the inferior crus. Attention is then turned to the upper lid, whose lateral mucocutaneous junction is trimmed using Westcott scissors. The gray lines of the lateral upper and lower eyelids arre reapposed using 6-0 Vicryl. The lateral canthal incisions are closed with a running 6-0 Prolene suture. Tobradex ointment is applied to the eye and eyelid. The patient is awakened and extubated and taken to the recovery room in stable condition. The patients will be examined at their post-operative week 1 and month 1 visits as per the usual standard of care. After the 1 month visit, their participation in the study is complete.
The tissue sections will be sent to the pathology department for sectioning and staining. The tissue will be sectioned through the follicles. The slides will be stained with hemotoxylin and eosin and Masson-Trichrome. The extent of tissue damage will be measured as the diameter of abnormal/damaged tissue in microns. The severity will be graded on a numerical scale from 0-3. The results will be compared among the 4 power settings.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low power | Experimental | Device: Radiofrequency ablationThese tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of "low." |
| 1 power | Experimental | Device: Radiofrequency ablationThese tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1. |
| 1.5 power | Experimental | Device: Radiofrequency ablationThese tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 1.5 |
| 2 power | Experimental | Device: Radiofrequency ablationThese tissue sections will receive radiofrequency ablation to each eyelash follicle at a power of 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationThe 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. | Device | 1 power, 1.5 power, 2 power, Low power |
Primary outcome
Extent of tissue damage
Time frame: Through study completion, approximately 6 months
The extent of damage will be measured on the tissue sections. The diameter of abnormal/damaged tissue will be measured in microns.
Severity of tissue damage
Time frame: Through study completion, approximately 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- BackgroundNakamoto, 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: PubMed 24505196Kim 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.
- Background: PubMed 8305373Kezirian GM. Treatment of localized trichiasis with radiosurgery. Ophthalmic Plast Reconstr Surg. 1993 Dec;9(4):260-6. doi: 10.1097/00002341-199312000-00006.
- Individual participant dataSharing planned: No. No plan to share with other researchers
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Sahu, MD principal investigator
Ochsner Health System
Jayne Weiss, MD principal investigator
Louisiana State University Health Sciences Center
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Trichiasis, run by Ochsner Health System.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Extent of tissue damage (time frame: Through study completion, approximately 6 months). The study lists 2 primary outcomes in all. 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 NCT03947723, which also lists 3 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 25 Apr 2023.