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

Not Applicable

Completed

• Conditions: Fuchs' Endothelial Dystrophy
• Interventions: Other: Placebo; Other: Hyperosmolar eye drops

• Registration Number: NCT04140422
• Lead Sponsor: University Eye Hospital, Freiburg

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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study Start: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lubricating Eye Drops	Placebo	Lubricating 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	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

Medical Center - University of Freiburg, Eye Hospital; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany