Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following DMEK Using Ultra-high Resolution OCT

Not Applicable

Completed

• Conditions: Fuchs' Endothelial Dystrophy
• Interventions: Device: Ultrahigh resolution Spectral Domain OCT

• Registration Number: NCT02542644
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Study Start: 2017-11-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Fuchs endothelial dystrophy scheduled for DMEK	Ultrahigh resolution Spectral Domain OCT	-

Primary Outcome Measures

Name	Time	Method
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).	1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK	Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Area of attached graft after DMEK	12 months after DMEK

Secondary Outcome Measures

Name	Time	Method
Number of patients in which rebubbling has to be performed	12 months
Number of patients needing retreatment	12 months
Best corrected visual acuity at 6 months using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).	6 months	Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Demographic risk factors such as gender	12 months
Demographic risk factors, such as family history	12 months
Demographic risk factors, such as smoking status	12 months
Central corneal thickness	12 months
Corneal endothelial cell count	12 months
Demographic risk factors such as age	12 months

Trial Locations

Locations (2)

Medical University Vienna, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria