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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperosmolar Eye Drops | Experimental | 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 | Placebo Comparator | Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in corneal backscatter over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrin Wacker, MD | University of Freiburg, Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center - University of Freiburg, Eye Hospital | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31415734 | Background | 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. | |
| 30104038 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 4, 2022 | |
| Reset | Apr 8, 2022 | |
| Release | May 26, 2022 | |
| Reset | Mar 2, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 4, 2022 | Apr 8, 2022 | |||
| May 26, 2022 |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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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.
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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.
|
| 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 |
|
|
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) |
| 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) |
| 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) |
| 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) |
| 3280235 | Background | Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18. |
| 33892048 | Derived | 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. |
| Mar 2, 2023 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |