Abstract Background The medical community is beginning to recognize that retinitis pigmentosa (RP), due to its disabling progression, eventually leads to a reduction in the patient´s quality of life, a direct economic impact, and an increase in the burden on the health care system. There is no curative treatment for the origin of the disease, and most of the current interventions fail in reducing the associated negative psychological states, such as anxiety and depression, which lead to increased variability of vision and pose a continuous threat to the patient’s independence. Objective The aim of this study is to assess the effect of oral melatonin (OM) administration alone and combined with short-wavelength light (SWL)–blocking filters on patients with RP and test their effectiveness in improving the level of stress and sleep problems in many of these patients. Methods We have developed a low-cost therapy protocol for patients with RP with sleep disorders and negative psychological stress. Patients will be randomized to receive a combined intervention with SWL-blocking filters and OM, SWL-blocking filters alone, or OM alone. There will also be a nonintervention arm as a control group. This study will be conducted across 2 retinal units in patients with RP with sleep disorders and high perceived stress and anxiety score reports. Patients will be assessed in the preintervention period, weekly during the 4 weeks of intervention, and then at 6 months postintervention. The primary outcomes are the differences in changes from baseline to postintervention in hormone release (α-amylase, cortisol, and melatonin) and sleep quality, as measured with the visual analog scale. Secondary outcome measures include clinical macular changes, as measured with optical coherence tomography and optical coherence tomography angiography; retinal function, as measured using the visual field and best-corrected visual acuity; sleep data collected from personal wearables; and several patient-reported variables, such as self-recorded sleep diaries, quality of life, perceived stress, and functional status. Results This project is still a study protocol and has not yet started. Bibliographic research for information for its justification began in 2020, and this working group is currently seeking start-up funding. As soon as we have the necessary means, we will proceed with the registration and organization prior to the preliminary phase. Conclusions In this feasibility randomized clinical controlled trial, we will compare the effects of SWL blocking alone, administration of OM alone, and a combined intervention with both in patients with RP. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as applied to additional inherited retinal dystrophies. The goal of presenting this protocol is to aid recent efforts in reducing the impact of sleeping disorders and other psychological disorders on the quality of life in patients with RP and recovering their self-autonomy. In addition, the results of this study will represent a significant step toward developing a novel low-cost therapy for patients with RP and validating a novel therapeutic target. International Registered Report Identifier (IRRID) PRR1-10.2196/49196 Keywords: retinitis pigmentosa, oral melatonin, short-wavelength light, intrinsically photosensitive retinal ganglion cells, ipGC, retinal dystrophy, quality of life, rare eye disease, eye disease, burden, health care system, intervention, treatment, vision loss, psychological stress, sleep disorder, eye, retina, cornea, lens, glaucoma, cataract
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Salvador Pastor-Idoate, Milagros Mateos-Olivares, Eva María Sobas et al.. Short-Wavelength Light–Blocking Filters and Oral Melatonin Administration in Patients With Retinitis Pigmentosa: Protocol for a Randomized Controlled Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/49196 Salvador Pastor-Idoate, Milagros Mateos-Olivares, Eva María Sobas, Miguel Marcos, Alfredo Toribio, José Carlos Pastor, Ricardo Usategui Martín
1Institute of Applied Ophthalmobiology, University of Valladolid, Valladolid, Spain 2Department of Ophthalmology, Clinical University Hospital of Valladolid, Valladolid, Spain 3Networks of Cooperative Research oriented to Health Results, National Institute of Health Carlos III, Madrid, Spain 4European Reference Network dedicated to Rare Eye Diseases, Valladolid, Spain 5Department of Ophthalmology, Clinical University Hospital of Caceres, Caceres, Spain 6Nursing School, University of Valladolid, Valladolid, Spain 7Department of Internal Medicine, University Hospital of Salamanca, Salamanca, Spain 8Institute of Biomedical Research of Salamanca, University of Salamanca, Salamanca, Spain 9Federation of Associations of Hereditary Retinal Dystrophies in Spain, Valladolid, Spain 10Department of Cellular Biology, Faculty of Medicine, University of Valladolid, Valladolid, Spain 