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Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is characterized by changes on the inside of the cornea, which leads to a substantial decline in visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.
Corneal transplantation Corneal transplantation surgery has seen major advances in the last decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has now become the preferred method.
Outcome There have been a substantial number of publications on outcome after DSAEK surgery, and the procedure has several advantages over the former preferred method of transplantation, penetrating keratoplasty (PK).
Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far results have been conflicting.
Hypotheses
Materials and methods
In a controlled prospective trial of DSAEK patients, we aim to register different morphological patterns, monitor visual performance and optical parameters.
Three sex and age-matched groups will be compared:
Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that undergo cataract surgery.
Investigation outline:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal corneas | No Intervention | Normal corneas from patients that undergo cataract surgery. | |
| DSAEK surgery | Other | Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSAEK surgery | Procedure | Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Up to 3 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Refractive properties, corneal clarity, subjective satisfaction | Subjective satisfaction will be measured using the Catquest 9SF questionnaire which uses a Likert scale which in turn is converted into a Rasch scale. The scales is linear, and uses a unit called the logit. | Up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esben Nielsen, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology | Aarhus | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27273977 | Result | Nielsen E, Ivarsen A, Kristensen S, Hjortdal J. Fuchs' endothelial corneal dystrophy: a controlled prospective study on visual recovery after endothelial keratoplasty. Acta Ophthalmol. 2016 Dec;94(8):780-787. doi: 10.1111/aos.13126. Epub 2016 Jun 7. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Manuscript | View IPD |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| D057111 | Descemet Stripping Endothelial Keratoplasty |
| D016039 | Corneal Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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To acces the results, please go to the above mentioned manuscript. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D054140 |
| Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |