UTDSAEK versus DMEK

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23947

Enrollment

Registered

2020-10-02

Start date

2021-05-27

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

Interventions

Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) or Descemet Membrane Endothelial Keratoplasty (DMEK)

Eligibility

Inclusion criteria

Inclusion criteria: - Age = 18 years. - Informed consent. - Fuchs’ endothelial dystrophy. - VA < 0.6 (Snellen). - Pseudophakia.

Exclusion criteria

Exclusion criteria: - Unable to attend the FU visits. - Previous keratoplasty in the eye to be included. - Severe progressive glaucoma (stable glaucoma on topical therapy is excepted). - History of retinal surgery, glaucoma surgery or age related macular disease. - Amblyopia. - Expected postoperative VA 1 quadrant. - Indication for typed graft.

Design outcomes

Primary

Measure	Time frame
Best corrected visual acuity (BCVA) at 12 months	—

Secondary

Measure	Time frame
BCVA at baseline and at 1, 3, 6 months postoperatively Number of graft detachments, rebubbling procedures or graft failures Endothelial cell density at 1 and 12 months Contrast sensitivity at baseline and at 12 months Root mean square of Zernike polynomials of high order aberrations	—

Contacts

Public ContactRene Wubbels

Het Oogziekenhuis Rotterdam / Rotterdams Oogheelkundig Instituut

r.wubbels@oogziekenhuis.nl010 4023430

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)