corneal endothelial cell dysfunction Fuchs dystrophy
Conditions
Interventions
In the iOCT optimized protocol the iOCT will be used to guide manipulation,
such as overpressure and corneal swiping. The classic protocol will be
performed if as no iOCT was present, including over
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age * 18 years Irreversible corneal decompensation caused by Fuchs corneal endothelial dystrophy or pseudophakic bullous keratopathy Eligible for posterior lamellar keratoplasty, specifically Descemet Membrane Endothelial Keratoplasty (DMEK)
Exclusion criteria
Exclusion criteria: Any ocular co-morbidity other than cataract, mild dry eye disease, ocular hypertension, simple primary open angle glaucoma, and mild age related macular degeneration Prior corneal transplant surgery Human leukocyte antigen (HLA) matched keratoplasty Any disability that will interfere with performing or understanding the procedures and questionnaire fulfilment except if it is temporary of nature. Combined phaco-emulsification-DMEK surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of post-operative surgical complications; specifically graft detachments, early graft failures, or induced iatrogenic acute glaucoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical time, both skin-to-skin and overall time in surgery (i.e. gross/net) 2. Best-corrected visual acuity at 3 and 6 months follow-up, as assessed using an ETDRS visual acuity chart. 3. Graft endothelial cell densities measured at 3 and 6 months follow-up. 4. Surgical manipulations will be scored considering the amount, duration, and the use of iOCT according to a study specific standard operating procedure. | — |
Countries
Netherlands
Outcome results
None listed