Purpose:

To evaluate the safety and efficacy of an artificial implant for the treatment of corneal edema secondary to endothelial failure.

Methods:

A thin silicone membrane with an adhesive coating was implanted on the posterior cornea of 6 rabbits and 10 pigs from which Descemet’s membrane and endothelial cells had been removed. Slit lamp examinations and corneal thickness (CT) measurements were performed for up to one year.

Results:

Three corneas of 6 rabbits that received a 7.0 mm implant remained clear with CT<600μ. a="" control="" eye="" remained="" edematous="" (ct="">600μ). There was a partial detachment with localized edema in 2 rabbits and corneal melting with perforation in 1 rabbit 4 months after implantation. After implant design changes, 6 corneas of 10 pigs that received a 7.5 mm implant that remained clear (CT<900μ) without="" melting,="" while="" 4="" control="" eyes="" remained="" edematous="" (ct="">2000 μ). Partial detachment of the implants led to moderate edema in 4 eyes.

Conclusions:

An artificial silicone implant could provide an alternative to endothelial keratoplasty that could be implanted through a small corneal incision and would not require human tissue or immunosuppression. Preliminary results are encouraging, but further development will be required to reduce the detachment rate.