Short-Wavelength Light–Blocking Filters and Oral Melatonin Administration in Patients With Retinitis Pigmentosa: Protocol for a Randomized Controlled Trial

JMIR Research Protocols · 7 authors, 10 centres

AI SUMMARY

FIDELITY 97%

POPULATIONPatients aged 18-65 years with moderate or severe retinitis pigmentosa (grading severity scale score >1 point) and sleep disorders/high perceived stress

INTERVENTIONShort-wavelength light (SWL)-blocking filters (goggles) worn during daylight/LED device use for 30 days; oral melatonin (6 mg) taken at 10:00 PM for 30 days; combination of SWL filters and oral melatonin

COMPARISONNo intervention control group

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

This paper outlines a randomized controlled trial protocol evaluating short-wavelength light (SWL)-blocking filters and oral melatonin (OM) in patients with retinitis pigmentosa (RP) who have sleep disorders and stress. The combined intervention is hypothesized to improve sleep quality, reduce stress, and regulate circadian rhythms better than either intervention alone or no intervention. Results will inform a novel low-cost therapy for RP, aiming to enhance quality of life and autonomy.

Full summary

3,246 CHARS

### Background Retinitis pigmentosa (RP) is the most common inherited retinal dystrophy, affecting over 1.5 million people worldwide with a prevalence of 1:4000. It is characterized by progressive photoreceptor degeneration, leading to vision loss. Patients often experience sleep-wake cycle abnormalities, stress, and reduced quality of life due to circadian rhythm disruption, partially mediated by intrinsically photosensitive retinal ganglion cells (ipGCs) sensitive to short-wavelength light (SWL, ~480 nm). Current therapies only slow progression. Short-wavelength light (415-455 nm) can cause photochemical retinal damage, while longer blue wavelengths (465-495 nm) are essential for circadian regulation. Oral melatonin (OM) has antioxidant and circadian phase-shifting effects. This protocol tests whether SWL-blocking filters (wavelengths <480 nm) and OM (6 mg) alone or in combination improve sleep, stress, and circadian markers in RP patients.

### Methods This is a single-site, parallel-group, double-blind RCT at the Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Spain. Eligibility includes age 18-65 years, moderate/severe RP (Iftikhar severity score >1), no recent ocular surgery or concurrent clinical trials, no allergy to melatonin, and no psychiatric disorders. Four groups (n=15 each, total 60): SWL-blocking goggles alone, OM alone (6 mg at 10 PM), SWL+OM, and no-intervention control. All participants complete 2-week preintervention sleep diaries. Intervention lasts 30 days, with weekly assessments during and at 6 months postintervention. Primary outcomes: changes in salivary α-amylase, cortisol, melatonin (ELISA), and sleep quality (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index). Secondary outcomes: best-corrected visual acuity (ETDRS), contrast sensitivity, visual field, optical coherence tomography (OCT/OCTA) metrics (central retinal thickness, macular ganglion cell thickness, vascular density), sleep diaries, State-Trait Anxiety Inventory (STAI), and perceived stress. Hair cortisol is also measured. Randomization uses permuted blocks; blinding of principal investigator and statistician. Adherence monitored via weekly calls. Sample size calculation: 60 participants (15 per group) provides 80% power (α=0.05) for a medium-high effect size (Cohen d=0.6). Statistical analysis uses linear mixed models, ANOVA, chi-square, and regression, adjusting for covariates. Intention-to-treat and per-protocol analyses planned.

### Key Results This is a protocol paper; no patient data or results are reported. The study has not yet started; funding is being sought. Bibliographic research began in 2020.

### Clinical Implications If successful, the combined noninvasive therapy (SWL filters + OM) could provide a low-cost, accessible treatment to improve sleep, reduce stress, and potentially slow retinal degeneration in RP patients. This would address significant unmet needs, as current therapies are limited and expensive. The protocol is designed for replication in other inherited retinal dystrophies and could reduce the impact of sleep and psychological disorders on quality of life. The study also aims to validate a novel therapeutic target (circadian axis) for RP.

PICO

PPOPULATION

Patients aged 18-65 years with moderate or severe retinitis pigmentosa (grading severity scale score >1 point) and sleep disorders/high perceived stress

IINTERVENTION

Short-wavelength light (SWL)-blocking filters (goggles) worn during daylight/LED device use for 30 days; oral melatonin (6 mg) taken at 10:00 PM for 30 days; combination of SWL filters and oral melatonin

OOUTCOME

Primary: changes in hormone release (salivary α-amylase, cortisol, melatonin) and sleep quality (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index). Secondary: macular changes (OCT/OCTA), retinal function (best-corrected visual acuity, visual field), sleep diaries, quality of life, perceived stress, functional status.

STUDY TYPE

RCT

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

97% · A

ORIGINAL PAPER

PMC10690531

Short-Wavelength Light–Blocking Filters and Oral Melatonin Administration in Patients With Retinitis Pigmentosa: Protocol for a Randomized Controlled Trial

JMIR Research Protocols

READ THE FULL PAPER

JUMP TO SECTION

ABSTRACT

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

CITATION EXPORT

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

AUTHORS

7 · 10 CENTRES

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