A Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK)

A Randomized, Comparative Trial of Two Posterior Lamellar Keratoplasty Techniques. Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) - UTDSAEK versus DMEK

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49409

Enrollment

Registered

2020-11-30

Start date

2021-05-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Fuchs endothelial dystrophy

Interventions

UTDSAEK or DMEK.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years. Informed consent. Fuchs* endothelial dystrophy. VA

Exclusion criteria

Exclusion criteria: Previous keratoplasty in the eye to be included. Severe progressive glaucoma. History of retinal surgery, glaucoma surgery or age related macular disease. Amblyopia. Expected postoperative VA

Design outcomes

Primary

Measure	Time frame
Number of letters gained at 12 months.	—

Secondary

Measure	Time frame
LogMAR Best Corrected Visual Acuity (BCVA) at baseline and at 1, 3, 6, 12 months. Rate of LogMAR BCVA recovery. Number of graft detachments / rebubling procedures. Number of graft failures. Endothelial cell density at 1 and 12 months. Contrast sensitivity at baseline and 12 months. RMS Zernike polynomials. Quality of vision at baseline and at 12 months. OT time.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)