20 Participants Needed

Contact Lens Wear for Fuchs' Dystrophy

SM
AQ
MC
Overseen ByMichael Cheung, MSc, CCRP
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Massachusetts Eye and Ear Infirmary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearing contact lenses affects the eyes of people with Fuchs' Dystrophy compared to those with healthy eyes. Researchers aim to determine if corneal swelling (thickness changes) differs after wearing the lenses for a few hours. Participants with Fuchs' Dystrophy must have a diagnosis and plan for a corneal transplant soon, while those with healthy eyes should have no history of eye diseases or surgeries. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the lenses work in people and measuring their effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking eye health research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that wearing contact lenses is safe for the eyes?

Research has shown that wearing contact lenses is usually safe for individuals with eye conditions, including Fuchs' Dystrophy. Studies have found that both soft and hard contact lenses can be worn safely for extended periods. For example, a study involving 50 firefighters who wore contact lenses for up to 10 months reported no major issues.

For those with Fuchs' Dystrophy, using special contact lenses with saline solution has reduced symptoms like eye swelling. These lenses were comfortable for most users, causing no significant discomfort or side effects.

Overall, while individual experiences may vary, research suggests that contact lenses are generally safe and comfortable for people with conditions like Fuchs' Dystrophy.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Fuchs' Dystrophy, such as corneal transplants or endothelial keratoplasty, this approach involves wearing a contact lens. Researchers are excited about this method because it offers a non-invasive way to potentially manage symptoms. The use of contact lenses could provide immediate relief and improve vision without surgery. This approach could simplify the management of Fuchs’ Dystrophy, making it accessible and convenient for more patients.

What evidence suggests that wearing contact lenses might be effective for Fuchs' Dystrophy?

This trial will compare the effects of wearing contact lenses in individuals with Fuchs' Endothelial Dystrophy (FECD) to those with healthy eyes. Research has shown that contact lenses might alleviate FECD symptoms. One report found that a special soft contact lens, used with a saline solution, reduced eye swelling, a common issue in FECD. Another study with firefighters found that both soft and hard contact lenses are safe for long-term use. Participants in these studies reported fewer symptoms, suggesting that contact lenses might help manage FECD. Overall, wearing contact lenses appears promising for reducing FECD symptoms.12456

Who Is on the Research Team?

UJ

Ula Jurkunas, MD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

This trial is for individuals with Fuchs endothelial corneal dystrophy (FECD) who are scheduled for a corneal transplant within the next 6 months. Participants should not have had previous eye surgery, contact lens intolerance, or other ocular diseases like glaucoma.

Inclusion Criteria

I am willing to undergo eye imaging tests.
I have been diagnosed with Fuchs' dystrophy.
I have never had eye diseases like surface issues or glaucoma.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Stress Test

Participants wear an FDA-approved contact lens for three hours to induce corneal swelling

3 hours
1 visit (in-person)

Recovery Monitoring

Participants are monitored for corneal recovery after the stress test

3 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the stress test

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Wearing of contact lens
Trial Overview The study aims to measure how much the cornea swells in response to wearing a contact lens as a stress test. It compares this swelling between people with healthy eyes and those with FECD before and after the test.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Subjects with healthy eyesExperimental Treatment1 Intervention
Group II: Subjects with Fuch's Endothelial DystrophyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials
115
Recruited
15,000+

Published Research Related to This Trial

A study involving 50 firefighters wearing contact lenses for up to 10 months showed that both soft and rigid gas permeable lenses can be worn safely, with no increased risk of injury or significant adverse effects specific to firefighting.
While some increases in eye irritation and corneal staining were observed, these effects are common among regular contact lens users and do not pose additional risks for firefighters, suggesting that soft contact lenses can be a viable option for visual correction in this profession.
Use of contact lenses by firefighters: Part 2. Clinical evaluation.Owen, CG., Margrain, TH., Woodward, EG.[2006]
Soft contact lenses can help manage conditions like recurrent corneal erosions and advanced bullous keratopathy, potentially improving patient comfort and aiding in tissue healing after surgery.
Rigid contact lenses are effective for patients with irregular astigmatism, providing a beneficial option for those with specific corneal dystrophies.
Contact Lenses in the Management of Corneal Dystrophies.Farooq, AV., Colby, K.[2020]
In a study of 22,739 contact lens wearers, the incidence of corneal ulcers was low for daily-wear lenses, but significantly higher for extended-wear lenses, indicating that overnight use increases the risk of serious eye complications.
Aphakic extended-wear soft lens users faced a ninefold increased risk of developing corneal ulcers compared to those using daily-wear cosmetic lenses, highlighting the importance of lens type and wear duration in eye health.
Corneal ulcer and adverse reaction rates in premarket contact lens studies.MacRae, S., Herman, C., Stulting, RD., et al.[2019]

Citations

Therapeutic contact lens for Fuchs endothelial corneal dystrophyThis case report demonstrates the effectiveness of a combined unique soft contact lens design and hypertonic saline at reducing corneal edema symptoms.
Contact Lens Wear for Fuchs' DystrophyA study involving 50 firefighters wearing contact lenses for up to 10 months showed that both soft and rigid gas permeable lenses can be worn safely, with no ...
Therapeutic contact lens for Fuchs endothelial corneal ...The patient reported a decrease in symptoms and his 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score was 19 after treatment.
IOL Selection for Patients With Corneal DiseaseExperts discuss considerations and controversies around selecting IOLs for patients with corneal disease, including keratoconus, Fuchs ...
Bitoric rigid gas permeable contact lenses in the optical ...The purpose of this study was to evaluate the complexity and effectiveness of fitting bitoric rigid gas permeable contact lenses (RGPCLs), compared to ...
Contact lenses in dry eye disease and associated ocular ...This review describes the role of soft lenses and rigid gas-permeable scleral lenses in the management of DED associated with OSD. The efficacy ...
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