FindTrial
Sign In

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).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24220
Enrollment
40
Registered
2014-12-15
Start date
2015-01-01
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 dysthrophy and indication for keratoplasty

Interventions

Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) Descemet Stripping Automated Endothelial Keratoplasty (DMAEK)

Sponsors

The Rotterdam Eye Hospital PO Box 70030 3000 LM Rotterdam 010- 401 77 77
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age &#8805; 18 years - Informed consent. - Fuchs endothelial dystrophy. - VA < 0.6 (Snellen).

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

MeasureTime frame
Number of letters gained at 12 months.—

Secondary

MeasureTime frame
LogMAR Best Corrected Visual Acuity (BCVA) at 1, 3, 6, 12 months. Rate of LogMAR BCVA recovery in both groups (RMANOVA). 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.—

Contacts

Public ContactJ van Rooij

The Rotterdam Eye Hospital

roi@oogziekenhuis.nl010- 402 34 49

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)