Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Hyperosmolar Eye Drops in Diurnal Corneal Edema in Fuchs Endothelial Dystrophy: a Double Blind Randomized Controlled Trial

Conditions
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Fuchs' Endothelial Dystrophy

Intervention / Treatment
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* Other: Hyperosmolar eye drops
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperosmolar Eye Drops<br>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 | Other: Hyperosmolar eye drops<br>* Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators<br>* Other names: ODM 5 (CE0459);|
| Placebo Comparator: Lubricating Eye Drops<br>Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered | Other: Placebo<br>* 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<br>* Other names: Placebo (for hyperosmolar eye drops);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal thickness | Tomography to determine the thickness of the cornea | Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal thickness over time | Tomography to determine the thickness of the cornea | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | 
| Change in corneal backscatter over time | Tomography to determine corneal backscatter | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | 
| Change in forward scatter over time | Stray light meter measurement to determine the forward scatter | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | 
| Change in visual acuity over time | Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts to determine visual acuity | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | 
| Change in subjective visual acuity | Question on presumed change of vision | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal edema, Descemet membrane endothelial keratoplasty (DMEK), Hyperosmolar eye drops