Fuchs' Endothelial Dystrophy
Conditions
Keywords
Corneal edema, Descemet membrane endothelial keratoplasty (DMEK), Hyperosmolar eye drops
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.
Interventions
OTHERHyperosmolar 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
OTHERPlacebo
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
Sponsors
University Eye Hospital, Freiburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The allocation is done randomly by the hospitals pharmacy. By using identical containers for the hyperosmolar eye drops and the lubricating eye drops participants and medical staff are not able to distinguish both substances.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal thickness | Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1) | Tomography to determine the thickness of the cornea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal thickness over time | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | Tomography to determine the thickness of the cornea |
| Change in corneal backscatter over time | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | Tomography to determine corneal backscatter |
| Change in forward scatter over time | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | Stray light meter measurement to determine the forward scatter |
| Change in visual acuity over time | Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9) | Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts to determine visual acuity |
| Change in subjective 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) | Question on presumed change of vision |
Countries
Germany
Outcome results
None listed