Version 1
: Received: 29 September 2023 / Approved: 29 September 2023 / Online: 29 September 2023 (15:18:42 CEST)
Version 2
: Received: 14 April 2024 / Approved: 24 April 2024 / Online: 24 April 2024 (15:25:40 CEST)
How to cite:
Musallam, I. M. Ocular Neuromodulation as a Novel Treatment for Retinitis Pigmentosa: Identifying Rod Responders and Predictors of Visual Improvement. Preprints2023, 2023092119. https://doi.org/10.20944/preprints202309.2119.v2
Musallam, I. M. Ocular Neuromodulation as a Novel Treatment for Retinitis Pigmentosa: Identifying Rod Responders and Predictors of Visual Improvement. Preprints 2023, 2023092119. https://doi.org/10.20944/preprints202309.2119.v2
Musallam, I. M. Ocular Neuromodulation as a Novel Treatment for Retinitis Pigmentosa: Identifying Rod Responders and Predictors of Visual Improvement. Preprints2023, 2023092119. https://doi.org/10.20944/preprints202309.2119.v2
APA Style
Musallam, I. M. (2024). Ocular Neuromodulation as a Novel Treatment for Retinitis Pigmentosa: Identifying Rod Responders and Predictors of Visual Improvement. Preprints. https://doi.org/10.20944/preprints202309.2119.v2
Chicago/Turabian Style
Musallam, I. M. 2024 "Ocular Neuromodulation as a Novel Treatment for Retinitis Pigmentosa: Identifying Rod Responders and Predictors of Visual Improvement" Preprints. https://doi.org/10.20944/preprints202309.2119.v2
Abstract
Starvation of photoreceptors induced by reduced dysregulated ocular blood flow is proposed as a common pathway for the pathogenesis of retinitis pigmentosa (RP). The current study evaluated the safety and efficacy of ophthalmic nerve stimulation (ONS) as an ocular blood flow neuromodulator, combined with ascorbic acid (AA) as a potent anti-oxidant in the treatment of RP. Additionally, the initial characteristics of rod responders were identified. Forty participants with simple, non-syndromic RP presented with a characteristic triad of RP (the bone spicule pigmentation, attenuation of retinal blood vessels, and waxy optic disc pallor), were en-rolled in a prospective open-label single-armed interventional study. The severity of the disease was clinically graded into six stages. Patients with an established diagnosis of RP; aged ≥ 4 years, with best corrected visual acuity (BCVA) ≥ 20/400 were included. All participants were daily treated with bilateral ONS sessions combined with intravenous administration of AA for two weeks. The primary efficiency endpoint was 6 months’ changes in scotopic vision as measured by a 10-item, 100-point, Low Luminance Questionnaire-10 (LLQ-10). The secondary efficiency points included best corrected visual acuity (BCVA) and contrast sensitivity. Rod responders were defined by ≥ 25 points increment of LLQ-10 score at 6 months after treatment. The results showed that ONS combined with AA treatment significantly improved low luminance vision, BCVA, and contrast sensitivity in patients with RP (p≤ 0.05). At 6-month visit, twenty-four (60%) patients were identified as rod responders and 16 (40%) patients were rod-non-responders. The mean change in LLQ-10 score was (46.35 ±16.81) in rod responders versus (4.9 ± 7.6) in non-responders (p < 0.0001). A clinically significant improvement of BCVA (≥0.2 logMAR) and contrast sensitivity (≥0.3 log unit) were demonstrated in 50% of the right eyes of rod responders. No serious adverse effects were reported and headache in 5 patients (12.5%) was the only en-countered side effect in this study. In conclusion, ocular neuromodulation is a safe therapeutic strategy for RP. It significantly improved night vision, BCVA, and contrast sensitivity. Determinants of rod responders include a shorter duration of night blindness, an earlier stage of the disease, and a relatively thicker ganglion cell layer at baseline. Additionally, two therapeutic scenarios were recognized; an early disease-modifying intervention that restores night vision and reverses the disease process and a late cone rescue intervention that improves/maintains central vision.
Keywords
Retinitis pimentosa; Ocular neuromodulation; Ophthalmic nerve stimulation; Ascorbic acid; Rod responders; Substance P; Night blindness
Subject
Biology and Life Sciences, Neuroscience and Neurology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.