Dry Eye Clinical Trial
Official title:
Effect of Trigeminal Nerve Stimulation on Subbasal Corneal Nerve Plexus Density and Chronic Ocular Pain in Patients With Dry Eye
Verified date | January 2022 |
Source | Instituto de Oftalmología Fundación Conde de Valenciana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | December 10, 2021 |
Est. primary completion date | December 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Oftalmología Conde de Valenciana | Mexico City | Cdmx |
Lead Sponsor | Collaborator |
---|---|
Instituto de Oftalmología Fundación Conde de Valenciana |
Mexico,
Aggarwal S, Kheirkhah A, Cavalcanti BM, Cruzat A, Colon C, Brown E, Borsook D, Prüss H, Hamrah P. Autologous Serum Tears for Treatment of Photoallodynia in Patients with Corneal Neuropathy: Efficacy and Evaluation with In Vivo Confocal Microscopy. Ocul Surf. 2015 Jul;13(3):250-62. doi: 10.1016/j.jtos.2015.01.005. Epub 2015 Feb 20. — View Citation
Alhatem A, Cavalcanti B, Hamrah P. In vivo confocal microscopy in dry eye disease and related conditions. Semin Ophthalmol. 2012 Sep-Nov;27(5-6):138-48. doi: 10.3109/08820538.2012.711416. Review. — View Citation
Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8. Review. — View Citation
Crane AM, Feuer W, Felix ER, Levitt RC, McClellan AL, Sarantopoulos KD, Galor A. Evidence of central sensitisation in those with dry eye symptoms and neuropathic-like ocular pain complaints: incomplete response to topical anaesthesia and generalised heightened sensitivity to evoked pain. Br J Ophthalmol. 2017 Sep;101(9):1238-1243. doi: 10.1136/bjophthalmol-2016-309658. Epub 2017 Jan 18. — View Citation
De Paiva CS, Corrales RM, Villarreal AL, Farley WJ, Li DQ, Stern ME, Pflugfelder SC. Corticosteroid and doxycycline suppress MMP-9 and inflammatory cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. Exp Eye Res. 2006 Sep;83(3):526-35. Epub 2006 Apr 27. — View Citation
Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6. Review. — View Citation
Farhangi M, Feuer W, Galor A, Bouhassira D, Levitt RC, Sarantopoulos CD, Felix ER. Modification of the Neuropathic Pain Symptom Inventory for use in eye pain (NPSI-Eye). Pain. 2019 Jul;160(7):1541-1550. doi: 10.1097/j.pain.0000000000001552. — View Citation
Galor A, Feuer W, Lee DJ, Florez H, Venincasa VD, Perez VL. Ocular surface parameters in older male veterans. Invest Ophthalmol Vis Sci. 2013 Feb 19;54(2):1426-33. doi: 10.1167/iovs.12-10819. — View Citation
Galor A, Moein HR, Lee C, Rodriguez A, Felix ER, Sarantopoulos KD, Levitt RC. Neuropathic pain and dry eye. Ocul Surf. 2018 Jan;16(1):31-44. doi: 10.1016/j.jtos.2017.10.001. Epub 2017 Oct 12. Review. — View Citation
Kalangara JP, Galor A, Levitt RC, Covington DB, McManus KT, Sarantopoulos CD, Felix ER. Characteristics of Ocular Pain Complaints in Patients With Idiopathic Dry Eye Symptoms. Eye Contact Lens. 2017 May;43(3):192-198. doi: 10.1097/ICL.0000000000000249. — View Citation
Karson CN, Burns RS, LeWitt PA, Foster NL, Newman RP. Blink rates and disorders of movement. Neurology. 1984 May;34(5):677-8. — View Citation
Kinard KI, Smith AG, Singleton JR, Lessard MK, Katz BJ, Warner JE, Crum AV, Mifflin MD, Brennan KC, Digre KB. Chronic migraine is associated with reduced corneal nerve fiber density and symptoms of dry eye. Headache. 2015 Apr;55(4):543-9. doi: 10.1111/head.12547. Epub 2015 Mar 31. — View Citation
Martinez JD, Galor A, Ramos-Betancourt N, Lisker-Cervantes A, Beltrán F, Ozorno-Zárate J, Sánchez-Huerta V, Torres-Vera MA, Hernández-Quintela E. Frequency and risk factors associated with dry eye in patients attending a tertiary care ophthalmology center in Mexico City. Clin Ophthalmol. 2016 Jul 21;10:1335-42. doi: 10.2147/OPTH.S106451. eCollection 2016. — View Citation
Matsumoto Y, Ibrahim OMA. Application of In Vivo Confocal Microscopy in Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES41-DES47. doi: 10.1167/iovs.17-23602. Review. — View Citation
Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, cortical spreading depression, sensitization, and modulation of pain. Pain. 2013 Dec;154 Suppl 1:S44-53. doi: 10.1016/j.pain.2013.07.021. Epub 2013 Jul 25. Review. — View Citation
Patel DV, McGhee CN. Mapping of the normal human corneal sub-Basal nerve plexus by in vivo laser scanning confocal microscopy. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4485-8. — View Citation
Sivanesan E, Levitt RC, Sarantopoulos CD, Patin D, Galor A. Noninvasive Electrical Stimulation for the Treatment of Chronic Ocular Pain and Photophobia. Neuromodulation. 2018 Dec;21(8):727-734. doi: 10.1111/ner.12742. Epub 2017 Dec 28. — View Citation
Small LR, Galor A, Felix ER, Horn DB, Levitt RC, Sarantopoulos CD. Oral Gabapentinoids and Nerve Blocks for the Treatment of Chronic Ocular Pain. Eye Contact Lens. 2020 May;46(3):174-181. doi: 10.1097/ICL.0000000000000630. — View Citation
Tavakoli M, Hossain P, Malik RA. Clinical applications of corneal confocal microscopy. Clin Ophthalmol. 2008 Jun;2(2):435-45. — View Citation
Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review. — View Citation
Zayan K, Aggarwal S, Felix E, Levitt R, Sarantopoulos K, Galor A. Transcutaneous Electrical Nerve Stimulation for the Long-Term Treatment of Ocular Pain. Neuromodulation. 2020 Aug;23(6):871-877. doi: 10.1111/ner.13146. Epub 2020 Mar 20. — View Citation
Zhang M, Chen J, Luo L, Xiao Q, Sun M, Liu Z. Altered corneal nerves in aqueous tear deficiency viewed by in vivo confocal microscopy. Cornea. 2005 Oct;24(7):818-24. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify the effect of trigeminal nerve stimulation on chronic eye pain in patients with dry eye. | Eye pain will be evaluated prior to the use of trigeminal nerve 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 trigeminal nerve stimulation with the same scale during monthly follow up. |
From three-six months | |
Primary | Identify the effect of trigeminal nerve stimulation on subbasal corneal nerve plexus density in patients with dry eye. | 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 trigeminal nerve stimulation use. |
2 months- 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |