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

Fuchs' Endothelial Dystrophy Clinical Trial

— EDEMAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140422
• Other study ID #: ETK 366/19
• Status: Completed
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: June 25, 2020

Study information

• Verified date: July 2020
• Source: University Eye Hospital, Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Medical Center - University of Freiburg, Eye Hospital	Freiburg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Eye Hospital, Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Fritz M, Grewing V, Maier P, Lapp T, Böhringer 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. — View 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. — View Citation

Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)