ADAGIO Study v1.0

  • Research type

    Research Study

  • Full title

    The Effect of Glaucoma Surgery on Aqueous Dynamics in Patients with Glaucoma or Ocular Hypertension – ADAGIO Study

  • IRAS ID

    333763

  • Contact name

    K. Sheng Lim

  • Contact email

    sheng.lim@gstt.nhs.uk

  • Sponsor organisation

    Guy's and St Thomas' NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    n/a, n/a

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    At present, there are various surgical treatments for people with glaucoma and high eye pressure (OHT). These treatments include different types of eye surgeries, trans-trabecular meshwork surgery with/without an implant, trans-scleral surgery with/ without implant, ciliary body treatment, suprachoroidal surgery with/without implant, external non-incisional treatment. However, we don't know much about how these surgeries affect the flow of fluid through and out of the eye (Aqueous Dynamics).

    To learn more about this, we're planning a study with 150 patients who need glaucoma surgery. We want to see how different surgeries (mentioned above) affect the aqueuos dynamics of the eye and how this might impact the results of the surgeries. We'll use the other non operated eye as a basis for comparison.

    Patients with glaucoma or high eye pressure who need surgery can join the study if they're not part of other studies. Before their surgery, we'll measure the fluid dynamics in their eyes, like eye pressure, how well fluid flows, and how much fluid the eye produces. To get accurate measurements, they'll stop using their glaucoma eye drops for a few weeks before these tests. This break from eye drops is part of the study because it's different from their usual care.

    These measurements will be taken before the surgery and again 3 and 12 months after the surgery. We'll also take these measurements again after another break from glaucoma eye drops for a few weeks, if the participants need to continue using these drops after the surgery. We'll compare the measurements before and after surgery using a statistical method called paired student t-tests.

    In addition to these measurements, we'll also do other eye tests at various times before and after the surgery. These tests are not normally done for glaucoma patients but are standard eye exams that are routinely done in eye clinics.

  • REC name

    West of Scotland REC 5

  • REC reference

    24/WS/0043

  • Date of REC Opinion

    30 Apr 2024

  • REC opinion

    Further Information Favourable Opinion