Clinical trial NCT02542644: Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following DMEK Using Ultra-high Resolution OCT
Official title: Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following Descemet's Membrane Endothelial Keratoplasty Using Ultra-high Resolution Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Keywords: Fuchs' Endothelial Dystrophy, DMEK
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Affected patients complain about blurred vision at early stages of the disease which can progress to blindness. The pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. Additional risk factors that have been identified are female sex, smoking and older age.

While for a long time penetrating keratoplasty (PKP) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. For FECD, this brings the advantage that only the diseased part of the cornea is replaced. Graft detachment has been identified as the main complication following DMEK.

In the investigators' study, an ultra high resolution OCT system will be used to detect graft detachment in patients with FECD after DMEK. With this technique, even small detachments can be visualized. The area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. A follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years scheduled for primary DMEK because of Fuchs' Endothelial Dystrophy

Exclusion Criteria:

* Any disease inhibiting OCT acquisition; such as blepharospasm, severe tremor or immobility
* Any previous intraocular surgery other than cataract extraction
* Previous clinically significant ocular trauma in the study eye, as judged by the investigator
* Pregnancy, planed pregnancy, or lactating
* Appointment of a custodian
* Progressive retinal disease
* History or presence of glaucoma

Primary outcomes:
measure: Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
timeFrame: 1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK
measure: Area of attached graft after DMEK
timeFrame: 12 months after DMEK
Secondary outcomes:
measure: Number of patients in which rebubbling has to be performed
timeFrame: 12 months
measure: Number of patients needing retreatment
timeFrame: 12 months
measure: Best corrected visual acuity at 6 months using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
timeFrame: 6 months
measure: Central corneal thickness
timeFrame: 12 months
measure: Corneal endothelial cell count
timeFrame: 12 months
measure: Demographic risk factors such as age
timeFrame: 12 months
measure: Demographic risk factors such as gender
timeFrame: 12 months
measure: Demographic risk factors, such as family history
timeFrame: 12 months
measure: Demographic risk factors, such as smoking status
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Clinical Pharmacology
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Katarzyna Witkowska, MD
role: PRINCIPAL_INVESTIGATOR
References: