Status:
COMPLETED
The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Maastricht University Medical Center
Universitaire Ziekenhuizen KU Leuven
Conditions:
Fuchs Dystrophy
Endothelial Corneal Dystrophy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize ...
Eligibility Criteria
Inclusion
- 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
- 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 (triple procedure)
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03763721
Start Date
November 13 2018
End Date
September 1 2022
Last Update
November 15 2022
Active Locations (3)
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1
Universiteitsziekenhuis Leuven
Leuven, Belgium
2
Maastricht University Hospital
Maastricht, Netherlands
3
University Medical Center Utrecht
Utrecht, Netherlands