Endothelial transplants of smaller size and/or lower cell density

Endothelial transplants of smaller size and/or lower cell density - Transplant size and/or cell density

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47809

Enrollment

Registered

2015-09-09

Start date

2016-01-24

Completion date

Unknown

Last updated

2024-04-23

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

All patients receive one surgery to implant the adapted transplant. Sometimes a 'rebubbling' might be necessary, as with regular DMEK. If the results are suboptimal after 6 months, an additional sur

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Fuchs endothelial dystrophy - Indication for a corneal transplant

Exclusion criteria

Exclusion criteria: - Concomitant ocular disease or a contraindication for this type of surgery

Design outcomes

Primary

Measure	Time frame
- Visual acuity, measured by the optometrist using a Snellen chart (standard procedure, also used for DMEK)	—

Secondary

Measure	Time frame
- Endothelial cell density, as assessed by specular microscopy. - Proportion of detachment, as assessed by OCT. - Number of 'rebubblings', re-transplants (includes re-surgery with a regular-sized transplant), and complications. - Pachymetry of the cornea, measured using a Pentacam apparatus and an Anterior Segment Optical Coherence Tomography apparatus (OCT).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)