Estimation of visual loss secondary to myopic maculopathy

  • Research type

    Research Study

  • Full title

    BOSU Study on Newly Presenting Visual Loss Secondary to myopic maculopathy

  • IRAS ID

    240420

  • Contact name

    Ajay Kotagiri

  • Contact email

    ajay.kotagiri@chsft.nhs.uk

  • Sponsor organisation

    City Hospital Sunderland NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Pathological myopia (PM) describes a series of degenerative disease processes in patients with a myopic refractive error of more than 6 dioptres (-6.00DS, spherical equivalent, or worse). Causes of visual loss affecting the macula include posterior staphylomata, lacquer cracks, choroidal neovascular membrane (CNVM) and myopic tractional maculopathy (MTM, comprising macular retinoschisis, epiretinal membrane, lamellar hole, and macular detachment). Attempts were made to stage pathological myopia, but have not been universally adopted.

    There are now licensed treatments for patients with myopic CNVM and the threshold to treat MTM is reducing with improving results. Although there is increasing interest in interventions to reduce the onset of myopia in children, there are no recognised treatments for other established degenerative changes.

    A recent UK Biobank study showed 4% of the UK population are highly myopic, and that myopia is more common amongst younger people, suggesting myopia is increasing. This would be in keeping with other current literature. Previous studies list degenerative myopia as the aetiology in 1.9-5.7% of those visually impaired, and 1.9-13.9% of those blind (World Health Organisation definitions). However, this data does not help us estimate the probability of a given individual of developing visual impairment due to untreatable causes and the proportion of patients with the various different maculopathies associated with myopia is poorly defined. Little is known about the clinical characteristics that may predispose to this, or the numbers at risk in UK.

    In the Phase 1 application, we estimated the total number of new registrations as sight impaired or severely sight impaired secondary to pathological myopia as 254 cases per year. Based on this calculation, we anticipate that a minimum of one year of surveillance will be required to ascertain an adequate number of cases for the study.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    19/SC/0373

  • Date of REC Opinion

    30 Sep 2019

  • REC opinion

    Further Information Favourable Opinion