PRO_010-2023, v1.0

• Research type

  Research Study

• Full title

  A prospective multicenter clinical study to evaluate the safety and effectiveness of intrastomal implantation of the Transform corneal Allograft (TCA) for providing near vision in presbyopic subjects - Long term follow-up

• IRAS ID

  335749

• Contact name

  Sheraz Daya

• Contact email

  sdaya@centreforsight.com

• Sponsor organisation

  Allotex Inc.

• Clinicaltrials.gov Identifier

  NCT06310252

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  The objective of this clinical study is to evaluate the long-term safety and effectiveness of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

  Patients previously implanted with the Allotex TCA will undergo a single, non-invasive examination visit to assess the safety and effectiveness of the inlay four years after implantation.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  24/WM/0084

• Date of REC Opinion

  20 May 2024

• REC opinion

  Further Information Favourable Opinion