Pilot-study; Investigation on the application of a new surgical technique (DMET) for treatment of Fuchs endothelial dystrophy

Pilot-study; Investigation on the application of a new surgical technique (DMET) for treatment of Fuchs endothelial dystrophy - DMET pilot-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44087

Enrollment

Registered

2013-04-26

Start date

2015-10-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs endothelial dystrophy / corneal weakness

Interventions

All patients will undergo 1 DMET operation. If the cornea fails to clear within 6 months, the patient will undergo a reoperation (DMEK).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients suffering from Fuchs endothelial dystrophy with no cells left in the center of the cornea, but still possessing cells at the periphery of the cornea.

Exclusion criteria

Exclusion criteria: When no endothelial cells are present in the peripheral part of the cornea

Design outcomes

Primary

Measure	Time frame
- visual acuity --> measured by the optometrist using a Snellen chart (standard procedure) - Pachymetry of the cornea --> measured using a pentacam apparatus and an Anterior Segment Optical Coherence Tomography apparatus (OCT) (standard procedures)	—

Secondary

Measure	Time frame
- Density of endothelial cells postoperative --> measured using a non-contact specular microscope (standard procedure)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)