Contact Lens Wear for Fuchs' Dystrophy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Pregnancy, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

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.

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}

Research Team

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.

Trial 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 (Procedure)

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+

CarolAnn Williams

Massachusetts Eye and Ear Infirmary

Chief Executive Officer

MBA from Harvard Business School

Aalok Agarwala

Massachusetts Eye and Ear Infirmary

Chief Medical Officer since 2019

MD from University of California, Los Angeles

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]

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]

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]

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]