NCT04895514

Gamma-Irradiated Corneal Inlay for Keratoconus

Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cornea and Laser Eye Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).

Detailed description

Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. Preserved corneal tissue is currently available commercially from CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such tissue is currently used in a number of eye surgical procedures. It is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Gamma-irradiated corneal tissue inlay	A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-06-01
• Completion: 2023-11-01
• First posted: 2021-05-20
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States