June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Real world evaluation of safety, compliance and retinopathy progression of the Noctura 400 Sleep Mask, a novel therapy for diabetic retinopathy
Author Affiliations & Notes
  • Jia Yu Ng
    Ophthalmology, James Cook University Hospital, Gateshead, United Kingdom
  • Esther Ting
    Ophthalmology, James Cook University Hospital, Gateshead, United Kingdom
  • A Fisher
    Polyphotonix, Durham, United Kingdom
  • Sophie Ridsdale
    Polyphotonix, Durham, United Kingdom
  • Luke Barclay
    Polyphotonix, Durham, United Kingdom
  • Daniela Collins
    Ophthalmology, James Cook University Hospital, Gateshead, United Kingdom
  • Footnotes
    Commercial Relationships   Jia Yu Ng, None; Esther Ting, None; A Fisher, Polyphotonix (E); Sophie Ridsdale, Polyphotonix (E); Luke Barclay, Polyphotonix (E); Daniela Collins, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 5029. doi:
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      Jia Yu Ng, Esther Ting, A Fisher, Sophie Ridsdale, Luke Barclay, Daniela Collins; Real world evaluation of safety, compliance and retinopathy progression of the Noctura 400 Sleep Mask, a novel therapy for diabetic retinopathy. Invest. Ophthalmol. Vis. Sci. 2017;58(8):5029.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Noctura 400 is a new, non-invasive, commercially available therapy for diabetic retinopathy. It uses organic light emitting diodes (OLEDs) and is designed to prevent dark adaptation during a patient’s sleep to reduce outer retina hypoxia and the rate of diabetic retinopathy progression. This study evaluates the safety, compliance and retinopathy progression in a community setting in the UK

Methods : Retrospective clinical notes review of patients who initiated Noctura 400 eye mask treatment between October 2014 and March 2015. Data from patients using the self- funded Noctura 400 eye mask were retrieved from the company log and diabetic eye screening records, with patient’s approval. 15 patients on Noctura 400 eye mask with at least one year follow up were recruited and consented for participation.

Demographic data, HBA1C level, duration of follow up, best corrected visual acuity (BCVA) in EDTRS letters, diabetic retinopathy grading at baseline, month 8 & month 16 were collected. Compliance of mask wear in this study was derived from actual mask usage data recorded by the device.

Results : 86% patients had Type 1 Diabetes and 14% with Type 2 diabetes. The mean age for the cohort was 56 +/- 11. Duration of follow up was 18 +/- 2 months.

Baseline BCVA in the study cohort was 74 +/- 18 in right eye (OD) and 67 +/- 28 in the left eye (OS). BCVA at month 8 and month 16 following initiation of OLED eye mask were 77 +/- 15 (OD) 61 +/- 27 (OS) and 72 +/- 19 (OD) 68 +/- 24 (OS) respectively. No significant safety signal was identified. Retinopathy grading at baseline ranged from no retinopathy (R0M0) to stable treated retinopathy (R3sM1P1) and remained stable during the study period.

The average duration from initiation of mask usage to study end point was 653 +/- 87 days. During the study period the mean nightly duration of mask use was 5 hours 11 minuets (+/- 1 hour 7 minutes), 65% of the 8 hour maximum nightly illumination provided by the mask.

Conclusions : This is the first report on real world evaluation of the Noctura 400 sleep mask therapy for diabetic retinopathy. In this group, it demonstrates good compliance and no progression of retinopathy during the study period. However, there is a possibility of response bias as the patients in a self-funded pilot may be more motivated than those in general population.

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

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