Pilot study of Navigated Subthreshold Microsecond Laser for DMO V1
Research type
Research Study
Full title
Pilot study of Navigated Subthreshold Microsecond Laser Treatment for Diabetic Macular Oedema
IRAS ID
201874
Contact name
Christina Rennie
Contact email
Sponsor organisation
University Hospital Soutampton
Duration of Study in the UK
1 years, 0 months, 19 days
Research summary
Diabetic Macular Oedema (DMO) is the leading cause of visual impairment in people with diabetes. DMO is swelling or thickening of the macula, the small area in the centre of the retina, which allows us to see fine details clearly. DMO is caused by fluid leaking from macular blood vessels damaged by diabetes. This causes blurred vision. Currently the treatment options include conventional supra-threshold thermal laser, and for those with more severe macular oedema, the use of injections of therapeutic substances into the eye. Conventional "supra-threshold" laser therapy uses a “continuous-wave”, or constant stream of laser energy to burn the retina leaving a visible change. In this study we would like to understand more about what occurs in patients with DMO when treated with Navigated Subthreshold Microsecond Laser using the NAVILAS laser. With micropulse the continuous-wave laser beam is chopped into tiny, repetitive, low energy pulses separated by a brief rest period in between. This allows the retina to cool between laser pulses, preventing retinal damage. Initial studies of micropulse laser to treat DMO show there are fewer side effects with no evidence of significant thermal damage to the retinal pigment epithelium (RPE: basal layer of retina), unlike conventional laser where burns to the RPE and retina are seen which can expand with time and cause visual loss. However there are no large randomised controlled trials, and those case series published use differing machines and settings and none of them use a navigated laser. The navigated laser gives tracking of retinal landmarks and ensures accurate placement of the laser treatment. This pilot study aims to assess the efficacy and safety of subthreshold micropulse laser using the NAVILAS laser (MPNL) as treatment for DMO with a view to then undertaking a larger randomised controlled trial.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0476
Date of REC Opinion
14 Dec 2016
REC opinion
Further Information Favourable Opinion