Corneal transplantation, Descemet's Membrane Endothelial Keratoplasty (DMEK)
Conditions
Brief summary
Step I (Year 1): The primary outcome of Step I, IOP elevation, is the development of IOP elevation, defined as an IOP ≥24 mmHg or an increase of ≥10 mmHg compared to preoperative baseline at any postoperative examination., Step II (Year 2): The primary outcome of Step II is the Endothelial Cell Loss (ECL) in the second year. This will be calculated based on specular microscopy images of the central cornea taken at 12 months and 24 months post-operatively
Detailed description
Rejection-free graft survival, Short-term trial-based economic evaluation (TBEE, cost-effectiveness analyses), Life-long model-based economic evaluation (MBEE, cost-effectiveness analyses), Patient-reported outcome measures (PROMs): vision-specific and generic health-related quality of life, patient experiences and satisfaction, and compliance, Best-corrected distance visual acuity (BCDVA), Structural outcomes: corneal, central macular, and retinal nerve fiber layer thickness
Interventions
Sponsors
University Hospital Maastricht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step I (Year 1): The primary outcome of Step I, IOP elevation, is the development of IOP elevation, defined as an IOP ≥24 mmHg or an increase of ≥10 mmHg compared to preoperative baseline at any postoperative examination., Step II (Year 2): The primary outcome of Step II is the Endothelial Cell Loss (ECL) in the second year. This will be calculated based on specular microscopy images of the central cornea taken at 12 months and 24 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Rejection-free graft survival, Short-term trial-based economic evaluation (TBEE, cost-effectiveness analyses), Life-long model-based economic evaluation (MBEE, cost-effectiveness analyses), Patient-reported outcome measures (PROMs): vision-specific and generic health-related quality of life, patient experiences and satisfaction, and compliance, Best-corrected distance visual acuity (BCDVA), Structural outcomes: corneal, central macular, and retinal nerve fiber layer thickness | — |
Countries
Germany, Netherlands
Outcome results
None listed