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Corneal transplantation by ultra-thin DSAEK: thinner grafts, better vision?

Corneal transplantation by ultra-thin DSAEK: thinner grafts, better vision?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25888
Enrollment
66
Registered
2011-10-14
Start date
2012-01-01
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

Irreversible corneal endothelial failure.

Interventions

The intervention consists of the performance of standard DSAEK or ultra-thin DSAEK.

Sponsors

Maastricht University Medical Center / University Eye Clinic Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for DSAEK or ultra-thin DSAEK are patients with: 1. Endothelial dysfunction caused by Fuchs’ endothelial dystrophy; 2. A minimum patient age of 18 years;

Exclusion criteria

Exclusion criteria: 1. Previous corneal transplantation; 2. Human leukocyte antigen typed keratoplasty; 3. Patients who are unable to communicate properly or to understand instructions.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is best corrected visual acuity (BCVA) 12 months postoperatively.

Secondary

MeasureTime frame
Secondary outcome measures are contrast acuity, refractive and topographic astigmatism, quality of vision (measured by contrast sensitivity measurements and stray light measurements), endothelial cell loss, incidence of graft rejection, primary graft failure, cornea donor loss due to preparation, and generic and vision-related quality of life (measured by validated questionnaires). Furthermore, adverse events, including complications, will be reported for each patient.

Contacts

Public ContactRudy M.M.A. Nuijts

University Eye Clinic Maastricht P.O. Box 5800

rudy.nuijts@mumc.nl+31 (0)43 3877344

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)