Advanced Visualization In Corneal Surgery Evaluation: Intra-operative Optical Coherence Tomography in posterior lamellar keratoplasty

Completed

Conditions: corneal endothelial cell dysfunction
Fuchs dystrophy
10015919

Registration Number: NL-OMON46771

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 39

Inclusion Criteria

Age * 18 years
Irreversible corneal decompensation caused by Fuchs corneal endothelial dystrophy or pseudophakic bullous keratopathy
Eligible for posterior lamellar keratoplasty, specifically Descemet Membrane Endothelial Keratoplasty (DMEK)

Exclusion Criteria

Any ocular co-morbidity other than cataract, mild dry eye disease, ocular hypertension, simple primary open angle glaucoma, and mild age related macular degeneration
Prior corneal transplant surgery
Human leukocyte antigen (HLA) matched keratoplasty
Any disability that will interfere with performing or understanding the procedures and questionnaire fulfilment except if it is temporary of nature.
Combined phaco-emulsification-DMEK surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The rate of post-operative surgical complications; specifically graft<br /><br>detachments, early graft failures, or induced iatrogenic acute glaucoma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Surgical time, both skin-to-skin and overall time in surgery (i.e. gross/net)<br /><br>2. Best-corrected visual acuity at 3 and 6 months follow-up, as assessed using<br /><br>an ETDRS visual acuity chart.<br /><br>3. Graft endothelial cell densities measured at 3 and 6 months follow-up.<br /><br>4. Surgical manipulations will be scored considering the amount, duration, and<br /><br>the use of iOCT according to a study specific standard operating procedure. </p><br>