IOP response to a short-term application of CPAP

  • Research type

    Research Study

  • Full title

    Intraocular pressure changes in response to continuous positive airway pressure during diurnal trial in people with treated primary open-angle glaucoma, treatment naïve primary open-angle glaucoma patients and control subjects.

  • IRAS ID

    201356

  • Contact name

    Ian Smith

  • Contact email

    ian.smith38@nhs.net

  • Sponsor organisation

    R&D, Papworth Hospital

  • Clinicaltrials.gov Identifier

    NCT03127813

  • Duration of Study in the UK

    0 years, 11 months, 24 days

  • Research summary

    Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent the onset of glaucoma. Some people with POAG also suffer from Obstructive Sleep Apnoea (OSA), an increasingly common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. OSA is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise IOP. The evidence for this is limited and the potential mechanisms involved are poorly understood.
    To investigate this issue we have designed two separate studies. In this application we are seeking an approval for the first study which aims to establish whether a short-term application of CPAP in awake subjects leads to an increase in IOP. Patients with treated POAG, patients with newly diagnosed untreated POAG and control subjects without glaucoma will be included. CPAP will be applied at several different pressure levels for a total of 2 hours during which IOP and ocular perfusion pressure (OPP) will be measured.
    This research will provide important data to guide treatment of OSA in people with Glaucoma. If CPAP is shown to raise IOP or alter OPP it will be necessary to assess available alternative treatment options for OSA. However, if CPAP does not have a detrimental effect on them, this would support our aim to assess the long-term effects of CPAP, most probably in the form of a randomised interventional trial, informed by the findings of this study.
    This study will be conducted at Papworth Hospital in collaboration with the Department of Ophthalmology at Hinchingbrooke Hospital.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    16/EE/0073

  • Date of REC Opinion

    4 Apr 2016

  • REC opinion

    Further Information Favourable Opinion