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

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyperosmolar eye drops
Placebo
Sponsored by
University Eye Hospital, Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy focused on measuring Corneal edema, Descemet membrane endothelial keratoplasty (DMEK), Hyperosmolar eye drops

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center - University of Freiburg, Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyperosmolar Eye Drops

Lubricating Eye Drops

Arm Description

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

Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered

Outcomes

Primary Outcome Measures

Change in corneal thickness
Tomography to determine the thickness of the cornea

Secondary Outcome Measures

Change in corneal thickness over time
Tomography to determine the thickness of the cornea
Change in corneal backscatter over time
Tomography to determine corneal backscatter
Change in forward scatter over time
Stray light meter measurement to determine the forward scatter
Change in visual acuity over time
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts to determine visual acuity
Change in subjective visual acuity
Question on presumed change of vision

Full Information

First Posted
October 23, 2019
Last Updated
July 14, 2020
Sponsor
University Eye Hospital, Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT04140422
Brief Title
Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea
Acronym
EDEMAS
Official Title
Efficacy of Hyperosmolar Eye Drops in Diurnal Corneal Edema in Fuchs Endothelial Dystrophy: a Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Eye Hospital, Freiburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy
Keywords
Corneal edema, Descemet membrane endothelial keratoplasty (DMEK), Hyperosmolar eye drops

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperosmolar Eye Drops
Arm Type
Experimental
Arm Description
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
Arm Title
Lubricating Eye Drops
Arm Type
Placebo Comparator
Arm Description
Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered
Intervention Type
Other
Intervention Name(s)
Hyperosmolar eye drops
Other Intervention Name(s)
ODM 5 (CE0459)
Intervention Description
Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for hyperosmolar eye drops)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in corneal thickness
Description
Tomography to determine the thickness of the cornea
Time Frame
Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1)
Secondary Outcome Measure Information:
Title
Change in corneal thickness over time
Description
Tomography to determine the thickness of the cornea
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)
Title
Change in corneal backscatter over time
Description
Tomography to determine corneal backscatter
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)
Title
Change in forward scatter over time
Description
Stray light meter measurement to determine the forward scatter
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)
Title
Change in visual acuity over time
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts to determine 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)
Title
Change in subjective visual acuity
Description
Question on presumed change of vision
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Wacker, MD
Organizational Affiliation
University of Freiburg, Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center - University of Freiburg, Eye Hospital
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31415734
Citation
Fritz M, Grewing V, Maier P, Lapp T, Bohringer 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.
Results Reference
background
PubMed Identifier
30104038
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.
Results Reference
background
PubMed Identifier
3280235
Citation
Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18.
Results Reference
background
PubMed Identifier
33892048
Citation
Zander DB, Bohringer D, Fritz M, Grewing V, Maier PC, Lapp T, Reinhard T, Wacker K. Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: A Double-Masked, Randomized Controlled Trial. Ophthalmology. 2021 Nov;128(11):1527-1533. doi: 10.1016/j.ophtha.2021.04.015. Epub 2021 Apr 20.
Results Reference
derived

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

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