Descemet Endothelial Thickness Comparison Trial II

Launched by STANFORD UNIVERSITY · Mar 2, 2022

Keywords

ClinConnect Summary

The Descemet Endothelial Thickness Comparison Trial II (DETECT II) is a research study looking at two different surgical treatments for patients with a condition called Fuchs endothelial dystrophy, which affects the cornea of the eye. This trial will randomly assign 60 participants to receive either a procedure called DMEK or a simpler technique known as Descemet Stripping Only (DSO), along with a medication called Ripasudil. The aim is to see which treatment works better for improving the health of the eye's inner layer.

To be eligible for this trial, participants must be at least 18 years old and have specific eye conditions related to Fuchs dystrophy. They should have a certain level of healthy endothelial cells in their eyes and be good candidates for surgery. Participants will need to agree to use the study medications and attend follow-up appointments after their surgery. If you or a loved one qualify and decide to participate, you can expect to receive careful monitoring and support throughout the process to ensure the best possible outcome for your eye health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
• • Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant
• • Good surgical candidate for either procedure as determined by the surgeon
• • Willingness to participate
• • Age greater than 18 years
• Exclusion Criteria:
• • Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
• • Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
• • Other primary endothelial dysfunction such as PPMD
• • Visually significant optic nerve or macular pathology
• • Hypotony (Intraocular pressure \<10mmHg)
• • Any prior intraocular surgery other than cataract surgery
• • \>3 clock hours of ANY anterior or posterior synechiae
• • \>1 quadrant of stromal corneal vascularization
• • Inability to comply with post-operative instructions (i.e. unable to position)
• • Pregnancy