Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea
NCT ID: NCT04140422
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2019-10-24
2020-06-25
Brief Summary
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Detailed Description
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During morning hours, patients with Fuchs' endothelial corneal dystrophy (FECD) typically report poor vision and disturbing glare because of corneal edema. To improve vision in advanced stages of the disease, corneal endothelial transplantation has become the treatment of choice. Many patients with Fuchs' endothelial corneal dystrophy (FECD) use hyperosmolar eye drops before transplantation. At present, it is unclear, how much hyperosmolar eye drops help reducing corneal edema in Fuchs' endothelial corneal dystrophy (FECD). Based on our previous work that determined the amount of additional corneal edema in the morning in patients with Fuchs' endothelial corneal dystrophy (FECD), the investigators will assess if hyperosmolar eye drops speed up the deswelling process.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyperosmolar Eye Drops
5% sodium chloride eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered
Hyperosmolar eye drops
Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators
Lubricating Eye Drops
Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered
Placebo
Application of one preservative-free lubricating eye drop, when waking up and one eye drop 30 min later to the fellow eye by the investigators
Interventions
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Hyperosmolar eye drops
Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators
Placebo
Application of one preservative-free lubricating eye drop, when waking up and one eye drop 30 min later to the fellow eye by the investigators
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
* Must be able to speak and understand German or English.
Exclusion Criteria
* Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, constant use of antihistamines, use of contact lenses in past four weeks, anesthetic eye drops, corticosteroid eye drops, antibiotic eye drops in past four weeks, glaucoma drops, hyperosmolar eye drops within the past 24 hours)
* Systemic diseases that affect the cornea (e.g. connective tissue disease, complicated diabetes mellitus)
* Lack of fixation during corneal tomography
18 Years
100 Years
ALL
No
Sponsors
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University Eye Hospital, Freiburg
OTHER
Responsible Party
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Katrin Wacker, MD
Principal Investigator
Principal Investigators
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Katrin Wacker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Freiburg, Eye Hospital
Locations
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Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Countries
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References
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Fritz M, Grewing V, Maier P, Lapp T, Bohringer D, Reinhard T, Wacker K. Diurnal Variation in Corneal Edema in Fuchs Endothelial Corneal Dystrophy. Am J Ophthalmol. 2019 Nov;207:351-355. doi: 10.1016/j.ajo.2019.08.002. Epub 2019 Aug 12.
Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.
Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18.
Zander DB, Bohringer D, Fritz M, Grewing V, Maier PC, Lapp T, Reinhard T, Wacker K. Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: A Double-Masked, Randomized Controlled Trial. Ophthalmology. 2021 Nov;128(11):1527-1533. doi: 10.1016/j.ophtha.2021.04.015. Epub 2021 Apr 20.
Other Identifiers
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ETK 366/19
Identifier Type: -
Identifier Source: org_study_id
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