Contact Lens Wear for Fuchs' Dystrophy

Overseen By Amy Quinkert, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment of wearing contact lenses for Fuchs' Dystrophy?

Research suggests that contact lenses, including soft and rigid types, can help manage various corneal conditions by improving comfort and visual performance. For example, soft contact lenses have been beneficial in managing corneal erosions and promoting healing after surgery, while rigid lenses can help with irregular astigmatism, which may be relevant for Fuchs' Dystrophy. ^{1 2 3 4 5}

Is wearing contact lenses generally safe for humans?

Contact lenses are generally safe for humans, but the risk of complications varies by type. Extended-wear soft lenses have a higher risk of complications like corneal ulcers compared to daily-wear lenses. Gas permeable lenses allow more oxygen to reach the eye, making them safer for prolonged use. ^{6 7 8 9 10}

How does contact lens wear differ from other treatments for Fuchs' Dystrophy?

Contact lens wear for Fuchs' Dystrophy is unique because it can help manage symptoms by providing a protective barrier and promoting comfort, especially after surgical procedures. Unlike other treatments, contact lenses can also help with irregular astigmatism by providing a stable surface for the eye, which is not typically addressed by standard medical or surgical treatments. ^{1 7 11 12 13}

What is the purpose of this trial?

The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Subjects with healthy eyes Experimental Treatment 1 Intervention

Persons with healthy eyes will wear a contact lens in one eye for three hours.

Group II: Subjects with Fuch's Endothelial Dystrophy Active Control 1 Intervention

Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact Lenses in the Management of Corneal Dystrophies. Farooq, AV., Colby, K.[2020]

In a study of 10 eyes with advanced atopic keratoconjunctivitis, the use of rigid gas-permeable scleral contact lenses significantly improved visual acuity, with all patients gaining at least one line of vision and most gaining two or more lines after fitting.

The scleral contact lenses were well tolerated, with no reported complications or infections, indicating they are a safe option for managing ocular surface issues in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of rigid gas-permeable scleral contact lenses in the management of advanced atopic keratoconjunctivitis. Margolis, R., Thakrar, V., Perez, VL.[2007]

In a study involving 34 participants with corneal ectasia, scleral rigid gas permeable contact lenses (SL) were found to be significantly more comfortable than corneal rigid gas permeable contact lenses (CoL), with higher subjective comfort scores reported for SL.

Despite the comfort advantage of SL, there was no significant difference in visual performance or quality of life between SL and CoL, indicating that both lens types provide similar visual outcomes for successful CoL wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of corneal vs. scleral rigid gas permeable contact lenses for keratoconus and other ectatic corneal disorders. Levit, A., Benwell, M., Evans, BJW.[2021]

The paper explores the relationship between epithelial basement membrane dystrophies and contact lens fitting, highlighting how these conditions can influence the choice of therapeutic and cosmetic contact lenses.

It discusses the safety and efficacy of extended wear hydrogels and rigid gas permeable lenses, providing case histories that demonstrate successful clinical outcomes in managing these eye conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New contact lens challenges: the epithelial basement membrane dystrophy. Siegel, D.[2004]

In a study of 232 new contact lens fittings, 69.3% of patients fitted with rigid gas permeable (GP) lenses for refractive reasons achieved successful fitting, while an impressive 96.7% of those fitted for therapeutic reasons were successful.

The study highlights that a standardized fitting protocol can lead to high success rates for GP contact lenses, providing valuable information for both patients and eye care practitioners in making informed decisions about lens options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Success of Rigid Gas Permeable Contact Lens Fitting. Ortiz-Toquero, S., Martin, M., Rodriguez, G., et al.[2017]

Extended-wear soft contact lenses are associated with a significantly higher risk of complications compared to gas-permeable hard lenses, with a relative risk of 2.7, indicating they may not be the safest option for new users.

Daily wear soft contact lenses also present risks, particularly for users with toxic or hypersensitivity disorders, where the relative risk is as high as 5.9, suggesting careful selection and monitoring of lens types is crucial for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. Stapleton, F., Dart, J., Minassian, D.[2019]

Gas permeable contact lenses provide superior oxygen permeability to the cornea compared to soft lenses, enhancing safety for both daily and extended wear.

These lenses improve visual quality and reduce the risk of allergic reactions to disinfecting solutions, as they do not absorb chemical preservatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas permeable lenses--a growing trend. Harrison, KW.[2004]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal ulcer and adverse reaction rates in premarket contact lens studies. MacRae, S., Herman, C., Stulting, RD., et al.[2019]

In a clinical trial involving 167 patients and 334 eyes, Menicon SF-P (melafocon A) rigid gas permeable contact lenses demonstrated safety for extended wear, with no significant adverse reactions reported and high comfort ratings (76% rated comfort as very good).

The study showed that these lenses can effectively maintain eye health over 12 months, with minimal keratometric shifts and only a small percentage of lenses needing replacement for issues like warpage, suggesting they are a viable alternative to disposable hydrogel lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective multicenter clinical trial to assess safety and efficacy of Menicon SF-P RGP lenses for extended wear. MacKeen, DL., Sachdev, M., Ballou, V., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of contact lenses by firefighters: Part 2. Clinical evaluation. Owen, CG., Margrain, TH., Woodward, EG.[2006]

Spherical rigid gas-permeable (RGP) contact lenses are effective for patients with pellucid marginal corneal degeneration (PMCD), providing good visual acuity ranging from 20/200 to 20/20 depending on the degree of astigmatism.

For optimal fitting, patients with less than 10 diopters of astigmatism should start with lenses having a base curve of 6.0 to 7.0 mm and a diameter of 8.0 to 9.5 mm, while those with more than 10 diopters should use a base curve of 7.0 to 7.5 mm and a diameter of 10.0 to 10.5 mm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nomogram for spherical RGP contact lens fitting in patients with pellucid marginal corneal degeneration (PMCD). Raizada, K., Sridhar, MS.[2015]

A combination lens design, featuring a rigid gas permeable center and a soft hydrophilic skirt, successfully provided comfortable daily wear for a patient with Pellucid Marginal Corneal Degeneration (PMCD) over 4 years.

Despite the patient's high astigmatism, the lens allowed for 20/20 visual acuity without causing significant corneal changes, indicating both the efficacy and safety of this lens design for managing PMCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term use of the SoftPerm lens on pellucid marginal corneal degeneration. Astin, CL.[2019]

In two case reports, rigid gas-permeable contact lenses were found to protect wearers from serious foreign body-related eye injuries.

While these lenses provided a protective effect in these cases, they are not officially recommended for use as protective eyewear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas-permeable contact lenses can protect against ocular trauma: two cases. Tang, K., Shah, A., McMahon, TT., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Contact Lenses in the Management of Corneal Dystrophies. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Role of rigid gas-permeable scleral contact lenses in the management of advanced atopic keratoconjunctivitis. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of corneal vs. scleral rigid gas permeable contact lenses for keratoconus and other ectatic corneal disorders. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

New contact lens challenges: the epithelial basement membrane dystrophy. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Success of Rigid Gas Permeable Contact Lens Fitting. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Gas permeable lenses--a growing trend. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Corneal ulcer and adverse reaction rates in premarket contact lens studies. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A prospective multicenter clinical trial to assess safety and efficacy of Menicon SF-P RGP lenses for extended wear. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Use of contact lenses by firefighters: Part 2. Clinical evaluation. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Nomogram for spherical RGP contact lens fitting in patients with pellucid marginal corneal degeneration (PMCD). [2015]

12. United States pubmed.ncbi.nlm.nih.gov

The long-term use of the SoftPerm lens on pellucid marginal corneal degeneration. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Gas-permeable contact lenses can protect against ocular trauma: two cases. [2019]