JMIR Publications

ABSTRACT

Background:

The medical community is beginning to recognize that Retinitis Pigmentosa (RP) due to its disabling progression, eventually leads to a reduction on patient´s quality of life, a direct economic impact, and an increase in the burden of the healthcare system. There is no curative treatment for the origin of the disease and most of the current interventions fail in reducing the negative psychological states such as anxiety and depression, which lead to increased variability of vision and posing a continuous threat to their independence.

Objective:

The aim of this study is to assess the effect of oral melatonin administration alone and combined with Short-Wavelength Light (SWL) blocking filters in patients with RP and test their effectiveness on improving the level of stress and sleep problems that many of these patients suffer from.

Methods:

We developed a low-cost therapy protocol among patients suffering from RP with sleep disorders and negative psychological stress. Patients will be randomized to either receive a combined intervention with blocking SWL filters and oral melatonin, blocking SWL alone and oral melatonin alone. There will be also a non-interventional arm as a control group. This study will be conducted across two retinal units in patients with RP with sleep disorders and high perceived stress and anxiety scores reports. Patients would be assessed at the pre-interventional period, weekly during the 4 weeks of intervention and then 6 months post-intervention. The primary outcomes metric are the differences in change from baseline to after intervention in hormone release (alpha-amylase, cortisol, and melatonin), and in sleep quality, as measured by the visual analogue scale. Secondary outcome measures would include clinical macular changes, measured by optical coherence tomography (OCT) and angio-OCT; retinal function measured by visual field and best corrected visual acuity, sleeping data collected from personal wearables and several patient-reported variables such as patient 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.

Conclusions:

We describe the methods for a feasibility randomized clinical controlled trial comparing with each other the effects of blocking SWL alone, oral melatonin alone and a combined intervention of both in RP patients. 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 ultimate 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 RP patients and recovering their self-autonomy. In addition, the results of this study will represent a significant step towards developing a novel low-cost therapy for RP patients and validating a novel therapeutic target.