Safety and Efficacy of Sub-Epithelial TCA for Presbyopia

• Research type

  Research Study

• Full title

  A PROSPECTIVE MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF SUB-EPITHELIAL IMPLANTATION OF THE TRANSFORM-CORNEAL ALLOGRAFT (TCA) FOR IMPROVING NEAR VISION IN PRESBYOPIC SUBJECTS

• IRAS ID

  253538

• Contact name

  Samer Hamada

• Contact email

  samer.hamada@qvh.nhs.uk

• Sponsor organisation

  Allotex, Inc

• Duration of Study in the UK

  2 years, 3 months, 4 days

• Research summary

  The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
  The Allotex TCA is a piece of acellular cornea, sterilized with electron beam radiation and shaped to a particular shape using a laser. The availability of precise laser shaping systems and sterile corneas are the key factors that make the use of allogenic implants possible. One size of the TCA is available which has a +2.50 D power with a diameter of 2-3.5 mm and a central thickness of 15-25 microns. The TCA is applied to the surface of the cornea at the layer known as Bowman’s membrane, which is just underneath the epithelium.
  The goal is to enhance the visual performance of the patient with a material that is 100% biocompatible and precisely shaped for the individual’s needs.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  18/NW/0673

• Date of REC Opinion

  15 Nov 2018

• REC opinion

  Further Information Favourable Opinion