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Effect of Transcutaneous Electric Stimulation on Corneal Nerves and Chronic Ocular Pain

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ClinicalTrials.gov Identifier: NCT04648085
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary:
Individuals with dry eye tend to present with ocular pain which persists despite the use of topical treatment. This could be secondary to somatosensory impairment attributable to neuropathic pain. The purpose of this study is to evaluate the effect of transcutaneous electric stimulation (TENS) on corneal nerves and chronic ocular pain in patients with dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Neuropathic Pain Eye Pain Device: Transcutaneous Electric Stimulation Not Applicable

Detailed Description:

Dry eye is a multifactorial disease that produces a variety of clinical manifestations including, dryness, pain, blurred vision, and sensitivity to light or wind. Differences have been noted between the symptoms reported and the signs presented on physical examination, which suggests the involvement of somatosensory impairment. Ocular neuropathic pain is characterized by burning pain, hyperalgesia, photophobia, and sensitivity to wind. There are common physiopathological pathways, suggesting that corneal nerve sensitization contributes to the development of dry eye symptoms. Furthermore, in vivo confocal microscopy has reported a decrease in the density of the subbasal plexus in patients with a neuropathic component and dry eye, suggesting that they are not mutually exclusive conditions. Various topical treatments, as well as systemic medications are known to manage eye pain and dry eye. However, in some cases, individuals have been refractory to them, enhancing the importance of research in adjuvant therapies such as TENS.

This research protocol evaluates the effect of transcutaneous stimulation on corneal subbasal plexus density and chronic eye pain in patients with dry eye. A complete dry eye examination will be performed, including completion of Ocular Surface Disease Index (OSDI) and Dry Eye Questionnaire-5 (DEQ-5). Subbasal nerves density will be measured by confocal microscopy before and after receiving treatment with TENS. In addition, monthly monitoring of the intensity of ocular pain (with a numerical scale of 0-10) will be maintained. The intensity and severity of the clinical variables will be compared before and after receiving the treatment with a paired Student's t-test considering an value of p<0.05 as statistically significant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open, single-arm pilot study without randomization.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Transcutaneous Electric Stimulation on Subbasal Corneal Nerve Plexus Density and Chronic Ocular Pain in Patients With Dry Eye
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Pre and Post Treatment with Transcutaneous Electric Stimulation
Individuals will receive treatment with transcutaneous electric stimulation for 20 minutes at a frequency of 100 Hertz (Hz). Ocular pain intensity will be recorded prior and after the use of therapy.
Device: Transcutaneous Electric Stimulation
Applied to to the forehead using a self-adhesive electrode positioned bilaterally over the upper branches of the trigeminal nerve.The device generates electrical impulses allowing to stimulate the trigeminal nerve.




Primary Outcome Measures :
  1. Identify the effect of transcutaneous electric stimulation on chronic eye pain in patients with dry eye. [ Time Frame: From three-six months ]

    Eye pain will be evaluated prior to the use of transcutaneous electric stimulation using a numeric pain scale ranging from 0-10, "0" indicating no pain and "10" indicating the most severe pain imaginable.

    Pain will be evaluated posterior to therapy with transcutaneous electric stimulation with the same scale during monthly follow up.


  2. Identify the effect of transcutaneous electric stimulation on subbasal corneal nerve plexus density in patients with dry eye. [ Time Frame: 2 months- 6 months ]

    Initial subbasal corneal nerve plexus density will be measured prior to therapy with with in vivo confocal microscopy.

    Density measurements will be repeated every two months with in vivo confocal microscopy posterior to transcutaneous electric stimulation use.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with dry eye, Ocular pain for more than 3 months, Contact lens users, Individuals using topical treatment and/or systemic medication for dry eye syndrome, Individuals with history of photo-ablative ocular surgery (Laser-assisted in situ keratomileusis (LASIK) , Photorefractive keratectomy (PRK), Small incision lenticule extraction(SMILE), Individuals with history of autoimmune disease (Lupus, Rheumatoid Arthritis, Sjögrens),

Exclusion Criteria:

  • Individuals with pacemakers or implantable defibrillators, Individuals with diagnosis of epilepsy, History of facial trauma one month prior to recruitment, Acute facial pain with unknown etiology, History of ocular surgery one month prior to recruitment, Trigeminal neuralgia, Active Herpes Zoster Ophthalmicus,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648085


Contacts
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Contact: Simran Mangwani Mordani, MD +52 5527078884 simranmangwanim@gmail.com
Contact: Arturo Ramirez Miranda, MD +52 5554530592 arturorammir@gmail.com

Locations
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Mexico
Instituto de Oftalmología Conde de Valenciana Recruiting
Mexico City, Cdmx, Mexico, 06800
Contact: Simran Mangwani Mordani, MD    +52 5527078884    simranmangwanim@gmail.com   
Contact: Arturo Ramirez Miranda, MD    +52 5554530592    arturorammir@gmail.com   
Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
Investigators
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Principal Investigator: Simran Mangwani Mordani, MD Instituto de Oftalmología Conde de Valenciana
Publications:

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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT04648085    
Other Study ID Numbers: CI-006-2020
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Transcutaneous Electric Stimulation
In vivo Confocal Microscopy
Subbasal Corneal Nerve Plexus
Dry Eye
Neuropathic Pain
Additional relevant MeSH terms:
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Neuralgia
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Pain
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Eye Manifestations