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 & DMEK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41108

Enrollment

Registered

2014-12-11

Start date

2015-09-14

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

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: 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
Number of letters gained at 12 months.	—

Secondary

Measure	Time frame
LogMAR Best Corrected Visual Acuity (BCVA) at 1, 3, 6, 12 months. Rate of vision recovery. Contrast sensitivity and stray light at 1, 3, 6 and 12 months. RMS (root mean square) of Zernike polynomials of total high order aberrations. Quality of vision questionnaire at 1, 3, 6 and 12 months. Endothelial cell density of the grafts at 6 and 12 months. Number of graft detachments. Number of graft failures. OT time and costs.	—

Measure

Time frame

LogMAR Best Corrected Visual Acuity (BCVA) at 1, 3, 6, 12 months. Rate of vision recovery. Contrast sensitivity and stray light at 1, 3, 6 and 12 months. RMS (root mean square) of Zernike polynomials of total high order aberrations. Quality of vision questionnaire at 1, 3, 6 and 12 months. Endothelial cell density of the grafts at 6 and 12 months. Number of graft detachments. Number of graft failures. OT time and costs.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)