216
Participants
Start Date
December 1, 2023
Primary Completion Date
May 1, 2028
Study Completion Date
November 30, 2028
Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light
A wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J/cm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 2 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea.
Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light
The corneal tissue for the control arm will be treated the same as the crosslinked tissue except that it will not be exposed to ultraviolet light. The donor cornea will be placed on an artificial anterior chamber maintainer and the epithelium will be removed mechanically. Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes.
Massachusetts Eye and Ear Infirmary, Boston
Joseph B. Ciolino, MD
OTHER