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

NCT02542644 | Completed DMC

• 1 other identifier: OPHT-013015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Fuchs' Endothelial Dystrophy

Keywords

Fuchs' Endothelial Dystrophy, DMEK

Outcome Measures

Primary Outcomes (2)

• 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).

  Visual acuity will be measured 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

• Area of attached graft after DMEK

  12 months after DMEK

Secondary Outcomes (9)

• 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

• Central corneal thickness

  12 months

• Corneal endothelial cell count

  12 months

Study Arms (1)

Patients with Fuchs endothelial dystrophy scheduled for DMEK

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

Interventions

Ultrahigh resolution Spectral Domain OCT DEVICE

The area of graft detachment will be measured by a customized ultra high-resolution OCT for the cornea. A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.

Patients with Fuchs endothelial dystrophy scheduled for DMEK

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Medical University Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katarzyna Witkowska, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 7, 2015
• Study Start: November 15, 2017
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (2)