Clinical trial NCT04140422: Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea
Official title: Efficacy of Hyperosmolar Eye Drops in Diurnal Corneal Edema in Fuchs Endothelial Dystrophy: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Keywords: Corneal edema
Descemet membrane endothelial keratoplasty (DMEK)
Hyperosmolar eye drops
Lead sponsor: University Eye Hospital, Freiburg
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses both eyes of the participant to allow inter- and intraindividual comparisons. One eye will be randomized to be treated with hyperosmolar eye drops, the fellow eye will be treated with lubricating eye drops.
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with Fuchs' endothelial corneal dystrophy (FECD). Each participant will receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.

Detailed description: Hyperosmolar eye drops are lubricating eye drops with 5% of sodium chloride. Hyperosmolar eye drops are thought to temporarily deswell the cornea.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
* Must be able to speak and understand German or English.

Exclusion Criteria:

* Other corneal diseases (i.e. epithelial defects except for bullae caused by Fuchs' endothelial corneal dystrophy (FECD), corneal scars, postoperative / bullous keratopathy, corneal degenerations / dystrophies, corneal inflammation / infection)
* 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

Primary outcomes:
measure: Change in corneal thickness
timeFrame: Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1)
Secondary outcomes:
measure: Change in corneal thickness over time
timeFrame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
measure: Change in corneal backscatter over time
timeFrame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
measure: Change in forward scatter over time
timeFrame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
measure: Change in visual acuity over time
timeFrame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
measure: Change in subjective visual acuity
timeFrame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Medical Center - University of Freiburg, Eye Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: University of Freiburg, Eye Hospital
name: Katrin Wacker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18.
citation: 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.