PULSAR

• Research type

  Research Study

• Full title

  Pilot Study of a Multi-Luminance Shape Discrimination Test (MLSDT) for use in Stargardt Disease Type 1 (STGD1)

• IRAS ID

  352802

• Contact name

  John Tobin

• Contact email

  john.tobin@splice.bio

• Sponsor organisation

  SpliceBio

• Duration of Study in the UK

  0 years, 9 months, 1 days

• Research summary

  This is a non-interventional study to evaluate the use of the Multi Luminance Shape Discrimination Test for examination of functional vision of Stargardt patients (STGD1).
  Stargard disease is an inherited eye condition that causes degeneration of light sensing cells (photoreceptors) in the retina and causes progressive loss of central vision.This study will involve Stargardt patients and healthy controls. There will be up to 120 eyes tested. Eyes will be assigned to 1 of 4 arms based on visual acuity (VA):good VA, moderate VA loss, or severe VA loss in STGD1 subjects (Arms 1-3, respectively) or normal vision in control subjects (Arm 4) without significant ocular disease.Each participant can have one or both eyes tested and can have VA associated with a different arm in one eye compared to the other.
  Patients and controls will be seen at the clinic 3 times over a period of up to 28 days All participants eligible to enter the study will undergo testing of visual acuity in the bright and dim light, will be asked to fill in quality of life questionnaires and will have the MLSDT done.
  The MLSDT is a non-invasive test that assesses the ability of subjects to recognise objects of different shapes and sizes in various light conditions. The testing box includes the following nine 3 Dimensional objects set up in a random order: pyramid, donut, brick, cylinder, cone, cube, sphere, stone and bowl. There are six object sizes. A computer program will request the patient to identify various shapes and sizes of objects under different light conditions.By changing the size of the objects and the lighting levels, the test informs us of an individual’s visual abilities comparable to day-to-day tasks.

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  25/WM/0018

• Date of REC Opinion

  26 Feb 2025

• REC opinion

  Further Information Favourable Opinion