ABSTRACT

Purpose:

To evaluate potential efficacy of a Class IIa 12 week medical device with CE certification and ISO13485 in treatment of chronic ME reluctant to pall previous other treatment.

Material & Methods:

10 patients included in this study (5 RVO, 1 DR, 1 post RD, 3 post ERM). All patients had multiple previous treatments for chronic ME, included ILM peeling, multiple anti-VEGF IVT, Corticosteroids IVT or subtenon, eyedrops, focal macular laser…all failed. The Noctura 400 sleep mask has 2 parts ; a fabric mask and a light emitting unit or “Pod”. The “Pod” contains 2 Organic Light Emitting Diodes (OLEDS) which are battery powered and when activated, deliver a precise dose of light therapy during a patient’s normal hours of sleep. It captures usage data which is downloaded on return of the device. These data are used to track compliance and can be compared with OCT scans to evaluate disease progression and treatment effectiveness. It is non invasive and non-toxic.

Results:

Majority of our patients surpringsily improved with Noctura, often in the first month. CMT decreased or normalized.

Discussion:

The wavelength of Noctura 400 has been selected to be absorbed primarly by the rod photoreceptors cells in retina, without affecting the cone PR, which could keep patients awake. When rod cells dark adapt, they require more oxygen. Noctura mask works by preventing the rod cells from dark adapting, thereby reducing the oxygen demand of the retinal cells and avoiding hypoxia. This slows or stops the production of VEGF which causes the production of leakage and ME. Noctura 400 has been used in more than 30 NHS hospitals and is still in research protocols for ME in DR.

Conclusion:

Further research is required for Noctura, but it is still for us a treatment for our patients with chronic and reluctant ME. Moreover, we think it could decrease the need of multiple anti-VEGF IVTs for all kinds of ME and reduce the cost for social care.


CONTACT DETAILS

 

Frédéric HAMON
Centre Helios Ophthalmologie
St Jean de Luz
France
Email : hamonpro@gmail.com
Cell Phone: +33662046330
Work Phone: +33559518660