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 of patient´s quality of life, a direct economic impact, and an increase in the burden of the healthcare system. There is no curative treatment and most of the current interventions fail in reducing the negative psychological states which lead to increased variability of vision and posing a continuous threat to patients' independence.

Methods:

We developed a low-cost therapy protocol among patients suffering from RP with sleep disorders and psychological stress. Patients will be randomized to receive either combined intervention including blocking low-wavelength light (LWL) plus oral melatonin or individual interventions 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 scores reports. 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 analog scale (VAS). Secondary outcome measures include clinical macular changes, retinal function, and several patient-reported variables such as patient self-recorded sleep diaries, quality of life, perceived stress, and functional status. Discussion: We describe the methods for a feasibility randomized clinical controlled trial comparing combined intervention, blocking LWL plus oral melatonin, to any intervention alone or no intervention. 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 patients´ quality of life 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.