Effect of Transcutaneous Electric Stimulation on Corneal Nerves and Chronic Ocular Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04648085|
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : October 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Neuropathic Pain Eye Pain||Device: Transcutaneous Electric Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|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|
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.
- 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.
- 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.
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
|Contact: Simran Mangwani Mordani, MD||+52 firstname.lastname@example.org|
|Contact: Arturo Ramirez Miranda, MD||+52 email@example.com|
|Principal Investigator:||Simran Mangwani Mordani, MD||Instituto de Oftalmología Conde de Valenciana|