Corneal Transplantation by DMEK - is it really better than DSAEK?

Corneal Transplantation by DMEK - is it really better than DSAEK? - DMEK study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43481

Enrollment

Registered

2016-05-19

Start date

2016-09-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' dystrophy

Interventions

The intervention group will receive cornea transplantation by DMEK. The usual care / control group will receive cornea transplantation by DSAEK.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Irreversible cornea decompensation caused by Fuchs Corneal Endothelial Dystrophy - A minimum patient age of 21

Exclusion criteria

Exclusion criteria: - Ocular comorbities other than cataract - Previous corneal transplantation - Human leukocyte antigen (HLA) matched keratoplasty - Inability to complete follow-up

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is best-corrected visual acuity.	—

Secondary

Measure	Time frame
Secondary outcome measures are contrast acuity, astigmatism, quality of vision, endothelial cell loss, incidence of graft rejection, primary graft failure, cornea donor loss due to preparation, and generic and vision-related quality of life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)