Clinical trial NCT04648085: Effect of Trigeminal Nerve Stimulation on Corneal Nerves and Chronic Ocular Pain
Official title: Effect of Trigeminal Nerve Stimulation on Subbasal Corneal Nerve Plexus Density and Chronic Ocular Pain in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Neuropathic Pain
Eye Pain
Keywords: Transcutaneous Electric Stimulation
In vivo Confocal Microscopy
Subbasal Corneal Nerve Plexus
Dry Eye
Neuropathic Pain
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open, single-arm pilot study without randomization.
Primary purpose: SUPPORTIVE_CARE

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 trigeminal nerve stimulation (TNS) on corneal nerves and chronic ocular pain in patients with dry eye.

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 TNS.

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 TNS. 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 t-test considering a value of p\<0.05 as statistically significant.

Eligibility 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,

Primary outcomes:
measure: Identify the effect of trigeminal nerve stimulation on chronic eye pain in patients with dry eye.
timeFrame: From three-six months
measure: Identify the effect of trigeminal nerve stimulation on subbasal corneal nerve plexus density in patients with dry eye.
timeFrame: 2 months- 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología Conde de Valenciana
state: Cdmx
Study officials:
affiliation: Instituto de Oftalmología Conde de Valenciana
name: Simran Mangwani Mordani, MD
role: PRINCIPAL_INVESTIGATOR
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