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Completed

NCT Number: NCT04140422

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

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.

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Key information

Conditions

Fuchs' Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Edema Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center - University of Freiburg, Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperosmolar eye drops

Other

Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators

Other names: ODM 5 (CE0459)

Placebo

Other

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

Other names: Placebo (for hyperosmolar eye drops)

Primary outcomes

  1. Change in corneal thickness

    Time frame: 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 outcomes

  1. Change in corneal thickness over time

    Time frame: 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

  2. Change in corneal backscatter over time

    Time frame: 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

  3. Change in forward scatter over time

    Time frame: 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

  4. Change in visual acuity over time

    Time frame: 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

  5. Change in subjective visual acuity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Eye Hospital, Freiburg

Other

Registry information

Official study title

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

Acronym: EDEMAS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2019
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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