Safety and Efficacy of the Transform Corneal Allograft for Hyperopia
Research type
Research Study
Full title
A PROSPECTIVE MULTICENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE TRANSFORM CORNEAL ALLOGRAFT (TCA) FOR TREATMENT OF HYPEROPIA
IRAS ID
250919
Contact name
Samer Hamada,
Contact email
Sponsor organisation
Allotex Inc.
Duration of Study in the UK
2 years, 3 months, 4 days
Research summary
The purpose of this clinical research investigation is to evaluate the safety and effectiveness of implantation of the Allotex TransForm corneal allograft (TCA) for improving distance vision in hyperopic patients. The expected duration of the clinical investigation is 3 years, subject participation will last 2 years.
The Allotex TCA is a small piece of sterile human tissue designed to change the shape of the first layer of the eye known as the cornea (which is like the crystal on a watch), to adjust the point of focus of light at the back of your eye. The tissue source is specially treated human corneas from an eye bank in the United States.
Following topical anesthesia, the surgeon first creates a pancake-like flap of the cornea using a laser. After the flap is created, your surgeon will place the TCA beneath the open flap and then complete the procedure by
re positioning the corneal flap on the eye. When the flap is replaced, it lies on top of the TCA, causing the surface to change shape which will attempt to improve your distance vision and reduce your dependence on corrective lenses (spectacles and/or contact lenses).
Up to 121 patients are being included in the clinical investigation.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0672
Date of REC Opinion
14 Nov 2018
REC opinion
Further Information Favourable Opinion