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Search for indicators of an upcoming allograft rejection after DMEK

Search for indicators of an upcoming allograft rejection after DMEK - Allograft rejection after DMEK

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44300
Enrollment
250
Registered
2017-11-09
Start date
2017-10-02
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 and bullous keratopathy / corneal disease

Interventions

Allograft rejection
Laser flare photometry

Sponsors

Melles Hoornvlieskliniek Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients with Fuchs endothelial dystrophy, bullous keratopathy or failed previous corneal transplant - Patient scheduled for DMEK surgery - 18 years and older

Exclusion criteria

Exclusion criteria: - Patients with ocular surface disease and delayed epithelial healing. - Patients with an additional corneal inflammation or other inflammatory disease. - Patient with concomitant ocular disease not related to the corneal disorder, or any type of circumstances that may be expected to adversely affect the efficacy of the surgery. - Severe diabetes. - Patients that may not be able to keep the position for 15 min. - Not able to understand the language used in the clinic (Dutch). - Inability to give informed consent for any reason

Design outcomes

Primary

MeasureTime frame
Changes in corneal layers as observed by confocal microscopy (e.g. increase in the number of activated keratocytes) that are typical before and/or during allograft rejection, significant changes in endothelial cell morphology and density, changes in intraocular inflammation levels by laser flare photometry.

Secondary

MeasureTime frame
- Endothelial cell density, as assessed by specular microscopy. - Pachymetry of the cornea measured using a Pentacam and/or an Anterior Segment Optical Coherence Tomography apparatus (AS-OCT). - Visual acuity, measured by the optometrist using a Snellen chart - Number of complications.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)