Investigative Ophthalmology & Visual Science Cover Image for Volume 65, Issue 7
June 2024
Volume 65, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2024
An exploratory, prospective, interventional, open-label, clinical trial with intranasal neurostimulation for ameliorating symptoms of neuropathic corneal pain
Author Affiliations & Notes
  • Onur Olcucu
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Gabriela Dieckmann
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Mehmet Cuneyt Ozmen
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Stephanie Cox
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Ginny Liu
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Pedram Hamrah
    Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Onur Olcucu None; Gabriela Dieckmann None; Mehmet Ozmen None; Stephanie Cox None; Ginny Liu None; Pedram Hamrah Novartis, Dompe, Oyster Point, Kala, Santen, OKYO, Code C (Consultant/Contractor), Novartis, Dompe, Coopervision, OKYO, Code S (non-remunerative)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2024, Vol.65, 2658. doi:
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      Onur Olcucu, Gabriela Dieckmann, Mehmet Cuneyt Ozmen, Stephanie Cox, Ginny Liu, Pedram Hamrah; An exploratory, prospective, interventional, open-label, clinical trial with intranasal neurostimulation for ameliorating symptoms of neuropathic corneal pain. Invest. Ophthalmol. Vis. Sci. 2024;65(7):2658.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Neuropathic corneal pain (NCP) is a debilitating disease with limited treatment options. Neuromodulation has been evolving for the treatment of chronic pain syndromes. This study aimed to investigate the efficacy of intranasal neurostimulation (ITNS) in ameliorating pain among NCP patients.

Methods : A total of 21 patients diagnosed with peripheral or mixed NCP were enrolled. Patients were instructed to use the ITNS device for three minutes each day, documenting alterations in pain intensity and changes in quality-of-life scores (QoL) through the Ocular Pain Assessment Survey daily. The clinical visits were scheduled at baseline, 30-days, and 90-days, and the clinical results along with the reasons for treatment discontinuation and the patterns of pain intensity changes (scale 0-10) were analyzed.

Results : The median age was 53.05±3.23 years and female/male ratio was 18/3. The pain intensities before ITNS showed a reduction of 18.15% at 30 days and 46.24% at 90 days compared to the baseline (p=0.11 and 0.16, respectively). Pain scores after ITNS changed from 5.73±0.45 to 1.92±0.36 (p <0.001) at baseline, 4.69±0.61 to 2.76±0.70 (p=0.005) at 30 days and 3.08±0.93 to 2.33±0.76 (p=0.41) at 90 days. Mean QoL scores gradually decreased with 6.46±0.55, 4.90±0.74 and 3.98±1.07 at baseline, 30-days, and 90-days, respectively (p=0.19). Seven (33.33%) out of 21 patients discontinued ITNS due to loss of effectiveness (n=3), induction of migraine attacks (n=2), increased pain intensity (n=1), and sinus infection (n=1). The changes in pain scores following ITNS stratified patients as responders (78.57%; continuous =28.57%, waning effect=28.57%, cyclic =21.43%) and non-responders (21.43%). Group of responders and non-responders demonstrated that burning sensation were reported as 86.81±3.58% and 30±10% for responder and non-responder groups respectively (p=0.009). Other factors did not demonstrate significant differences between groups.

Conclusions : ITNS can be effective in relieving pain symptoms in most patients with peripheral and mixed NCP, in particular in patients with burning. However, within responders, there seem to be variable patterns, with some patients potentially developing tolerance to ITNS. Neurostimulation presents a promising adjunct treatment for NCP and future prospective randomized trials are warranted.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

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