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Descemetorhexis only* for treatment of Fuchs endothelial dystrophy

Descemetorhexis only* for treatment of Fuchs endothelial dystrophy - *Descemetorhexis only* for FED

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45640
Enrollment
20
Registered
2017-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Fuchs endothelial dystrophy / corneal disease

Interventions

The intervention includes removal of the diseased DM, endothelial cells and guttae from the central part of the cornea by manual surgery and/or low energy YAG laser. This area will be filled in by e
Descemet Membrane

Sponsors

Melles Hoornvlieskliniek Rotterdam (MHR)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Fuchs endothelial dystrophy - Indication for a corneal transplant - Age * 18 years - Agree to return for 1 day, 1 week, 1 month, 3 months 6 months, 9 months, and 12 months post-procedure follow-up visits

Exclusion criteria

Exclusion criteria: - Concomitant ocular disease and/or a contraindication for this type of treatment (e.g. inflammation of the eye, uveitis etc.) - (Functional) oculus ultimus - Severe diabetes - Unable to sit on a chair in front of the laser for 30 minutes - Unable to clearly understand the language used in the clinic (Dutch) - Inability to give informed consent for any reason - Pregnant or nursing

Design outcomes

Primary

MeasureTime frame
- visual acuity, measured by the optometrist using a Snellen chart (standard procedure, also used for DMEK).

Secondary

MeasureTime frame
- endothelial cell density, as assessed by specular microscopy and confocal microscopy, - number of complications, - pachymetry of the cornea, measured using a Pentacam apparatus and an Anterior Segment Optical Coherence Tomography apparatus (AS-OCT), - corneal clarity; if the cornea fails to clear within the first 6 months after surgery, the patient will receive a re-operation (DMEK). - intraocular level of inflammation as measured with laser flare photometry

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)