Investigating the Arden hypothesis: a pilot investigation of the prevention of dark adaptation as complementary therapy for diabetic retinopathy and macular edema

Abstract

Purpose : To evaluate the acceptability of an illuminated sleep mask in patients with clinically significant diabetic macular edema.

Methods : Patients with refractory diabetic macular edema, who demonstrated a poor or delayed response to anti-VEGF treatment, were offered the opportunity to pilot the use of an illuminated sleep mask as complementary therapy along side their ongoing treatment with intravitreal injections. Two questionnaires, the Epworth sleepiness scale (ESS) and Pittsburgh insomnia rating scale-20 item version (PIRS-20), were used to screen for preexisting sleep disorder and repeated over the course of the six month trial to look for evidence of disturbed sleep. In addition, patients completed a sleep log and survey about the comfort and usability of the light mask over the course of the six month trial.

Results : A lighted sleep mask was accepted by 86% of patients who trialed the device (n=6). Sleep duration, quality and daytime sleepiness did not significantly change from baseline over the six month trial. ESS decreased from 3.6±2.1 at baseline to 1.6±2.5 at 1 month and 2.5±2.3 at six months (N.S.). PIRS-20 remained stable from 7.4±4.8 at baseline to 5.2±2.9 at 1 month and 7.7±3.9 at six months (N.S.). Patients slept an average of 7.8±0.9 hours per night using the mask. No significant change in sleep duration occurred during the course of the trial. Most patients used the mask continuously and without difficulty, returning logs that documented nightly battery changes. Roughly half of patients had gaps in their use of the device due to mask failure, unrelated medical problems, or loss of health insurance; 83% of patients completed the six month trial (n=5).

Conclusions : “Light masks” are readily accepted and well tolerated by a majority of patients requiring ongoing treatment for clinically significant diabetic macular edema. In those patients who accept the intervention, no adverse events were encountered and sleep duration and quality remained stable. The present study was under powered to establish whether the masks caused any reduction in diabetic macular edema. Ongoing randomized, controlled trials are needed to establish the benefit of light-at-night for those patients with sight-threatening diabetic retinopathy.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.