Double port injector device to reduce endothelial damage in DMEK

Area of Science:

• Ophthalmology
• Corneal Surgery
• Cell Biology

Background:

• Descemet Membrane Endothelial Keratoplasty (DMEK) is a surgical procedure for endothelial dysfunction.
• Minimizing endothelial cell loss during graft insertion is crucial for DMEK success.
• Existing insertion devices may cause variable levels of endothelial trauma.

Purpose of the Study:

• To evaluate the efficacy of a newly designed asymmetric double port DMEK injector in minimizing endothelial injury.
• To compare the novel injector's performance against a standard single port pipette in laboratory settings.
• To assess clinical outcomes regarding endothelial cell loss after DMEK using the new device.

Main Methods:

• Ex-vivo laboratory study using rabbit endothelial rolls and a no-touch technique.
• Comparison of endothelial cell survival after injection with a single port pipette versus the novel double port injector.
• Interventional case series involving six patients undergoing DMEK with the new device, with 3-month follow-up for endothelial cell loss.

Main Results:

• The double port injector resulted in significantly higher endothelial cell survival (96.8%) compared to the single port pipette (78.8%) in ex-vivo experiments (P=0.008).
• Clinical application of the double port injector showed early endothelial cell loss of 26.1% at 3 months post-surgery.
• The observed clinical cell loss was comparable to rates reported by experienced DMEK surgeons.

Conclusions:

• The asymmetric double port DMEK injector significantly reduces endothelial cell damage compared to single port devices in ex-vivo models.
• The novel injector demonstrates clinical safety and efficacy, achieving early endothelial cell loss rates comparable to established surgical series.
• This device represents a promising advancement for improving DMEK graft survival and surgical outcomes.