4.5-Year Follow-up with a Novel Corneal Endothelial Prosthesis.

Area of Science:

• Ophthalmology
• Biomaterials Science
• Regenerative Medicine

Background:

• Refractory corneal edema necessitates endothelial keratoplasty (EK), but donor tissue limitations restrict access.
• Current EK procedures like DMEK and DSAEK face challenges with tissue availability and logistics.
• An endothelial corneal keratoprosthesis could address graft failure risks and tissue scarcity in underserved regions.

Purpose of the Study:

• To evaluate the safety and efficacy of the EndoArt corneal prosthesis.
• To assess device adherence, visual acuity, and corneal thickness changes post-implantation.
• To determine the potential of EndoArt as an alternative to traditional EK.

Main Methods:

• A case cohort series of 10 eyes implanted with the EndoArt corneal prosthesis.
• Follow-up duration of up to 4.5 years.
• Outcome measures included device adherence, central corneal thickness, visual acuity, and adverse events.

Main Results:

• Device adherence was achieved and maintained in 90% of eyes.
• Mean central corneal thickness significantly decreased from 927 to 621 microns.
• Visual acuity improved in 60% of patients, with no pathological corneal changes observed.

Conclusions:

• The EndoArt demonstrated stable reduction in corneal thickness and improved vision in a majority of patients.
• No device-related adverse events were reported, indicating a favorable safety profile.
• EndoArt serves as a valuable treatment option for repeat corneal graft failure and in areas with limited donor tissue access.