Descemet Membrane Endothelial Keratoplasty for Fuchs' Endothelial Dystrophy

Phase-Based Estimates
1
Effectiveness
2
Safety
Devers Eye Institute, Portland, OR
Fuchs' Endothelial Dystrophy
Descemet Membrane Endothelial Keratoplasty - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Fuchs' Endothelial Dystrophy

Study Summary

Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Descemet Membrane Endothelial Keratoplasty will improve 1 primary outcome and 3 secondary outcomes in patients with Fuchs' Endothelial Dystrophy. Measurement will happen over the course of 6 months.

6 months
Best corrected visual acuity
Endothelial cell density
Post surgery complications
Time to corneal clearance

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo Control
Glanatec
Placebo group

This trial requires 72 total participants across 2 different treatment groups

This trial involves 2 different treatments. Descemet Membrane Endothelial Keratoplasty is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

GlanatecGlanatec eye drops will be administered 6x per day for 2-4 weeks
Placebo ControlOptive artificial tears will be administered 6x per day for 2-4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Descemet Membrane Endothelial Keratoplasty
2014
N/A
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Devers Eye Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The peripheral cornea to the central 6mm is devoid of guttata changes.
Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is fuchs' endothelial dystrophy?

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Since the most common cause of blindness is the development of FSD, a better understanding of the disease may lead to the development of treatments which minimize the impact of the disorder and halt the progression of the disease. A multidisciplinary team of ophthalmologists, pathologists, and patient advocate will be essential for patient care.

Unverified Answer

Can fuchs' endothelial dystrophy be cured?

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FED can go away in some individuals, but is usually irreversible at some point during the natural development of the disease. It is extremely variable and the time in which the edema is noticed may vary from hours post operatively to decades after the eye was first operated. There is no cure for FED.

Unverified Answer

What are common treatments for fuchs' endothelial dystrophy?

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The initial management of FED should be focused on correction of ocular hypotony and the eye examination by a competent ophthalmologist must be obtained (ophthalmologist is essential). Fluorescein angiography and spectral domain optical coherence tomographic imaging help to diagnose and to follow the progression of FED in a clinical setting. No curative treatment for this disease is available. Management focuses on decreasing further deterioration of the eye and on preventing or treating complications. Treatment options are available for many types of complications.

Unverified Answer

How many people get fuchs' endothelial dystrophy a year in the United States?

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FECD is an underdiagnosed and underresearched eye disease among the US population, which suggests that it may be more common than previously recognized. Better understanding of the disease and awareness of the disease among ophthalmologists and other primary care providers may allow earlier preventive measures to be taken.

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What are the signs of fuchs' endothelial dystrophy?

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Vision changes in Fuchs' endothelial dystrophy may be related to retinal detachment. Some signs include cataract formation, visual field restriction, loss of central corneal endothelial signal, loss of central visual acuity and photophobia. Diagnosis is usually evident during adolescence, and in a subset of cases, retinal detachment may be a very early sign of FED. Thus, screening for FED, such as an examination of the retina, should be considered for any patient with bilateral vision problems before the age of 10 years.

Unverified Answer

What causes fuchs' endothelial dystrophy?

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It is considered impossible to define a cause of FED. The current theories are: vascular lesions that may not be due to a systemic immune-mediated process, and a metabolic or nutritional insult that may affect the blood vessels, either before or during development. The most likely hypothesis is that environmental factors have a synergistic effect with inheritance. The clinical appearance of FED is usually a consequence of irreversible damage to the vascular endothelium, which leads to a loss of the vascular tone, which in turn causes vessel collapse.

Unverified Answer

Has descemet membrane endothelial keratoplasty proven to be more effective than a placebo?

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Descemet membrane endothelial keratoplasty was more effective than a 1-week regimen of topical steroid eye drops for the treatment of Fuchs' endothelial corneal dystrophy. Treatment with either treatment did not enhance recovery or improve the functional results of this most effective procedure for corneal edema and photophobia.

Unverified Answer

Is descemet membrane endothelial keratoplasty typically used in combination with any other treatments?

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DMEK is being combined with many different treatment modalities, though some studies have found poorer outcomes when combined with phacoemulsification. It is unclear if this is the case for DMEK as an intravitreal injection.

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How serious can fuchs' endothelial dystrophy be?

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The vision-threatening and life-threatening complications of FED can be life-threatening when untreated for a prolonged period of time. It is recommended that ophthalmologists evaluate these patients when they are younger than 46 years old because some symptoms may also occur at an older age.

Unverified Answer

What are the common side effects of descemet membrane endothelial keratoplasty?

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Descemet membrane endothelial keratoplasty can be a rewarding method of corneal graft, especially if one of the main surgeons is experienced with this form of keratoplasty. The early postoperative period can be challenging, although patients are likely to be more comfortable with the surgery during this period as they recover from anesthesiologic and surgical pain, and have time to focus on the physical demands of postoperative rehabilitation. The main postoperative complications are usually minor, but the incidence of severe complications is not negligible.

Unverified Answer

Have there been any new discoveries for treating fuchs' endothelial dystrophy?

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Currently, researchers are working on the pathogenesis of the disease. It is believed that there are various genes or combinations of genes that are involved in the development of fuchs' dystrophy, as well. Once determined, the genes will be used to block or activate the genes or proteins that are implicated in fuchs' dystrophy.

Unverified Answer

What are the latest developments in descemet membrane endothelial keratoplasty for therapeutic use?

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The DMEK was successfully used for the management of FED in this study. It can be performed as a temporary, single-entry, endothelial-only procedure, similar to that of corneal transplants. This approach is a reasonable alternative to corneal transplantation for the management of FED in cases in which a corneal graft is rejected or in severe corneal complications. With the right conditions, DMEK can be performed with low risks and low postoperative complications.

Unverified Answer
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