Corneal Crosslinking for Keratoconus

Overseen By Brian J McNeel, OD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McNeel Eye Center

Disqualifiers: Corneal transplantation, pregnancy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a treatment called Corneal Cross Linking to determine its effectiveness for individuals with keratoconus, pellucid marginal degeneration, or post-LASIK ectasia. These conditions cause the cornea, the eye's clear front surface, to weaken and bulge, impairing vision. The trial tests various application methods to identify the most effective one. Individuals diagnosed with keratoconus or similar corneal issues may be suitable candidates for this study. As an unphased trial, it provides an opportunity to explore innovative methods for enhancing vision health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Corneal Cross Linking is safe for treating keratoconus?

Research has shown that corneal cross-linking (CXL) is generally safe for treating eye conditions like keratoconus and pellucid marginal degeneration. Studies indicate that CXL can prevent these conditions from worsening and may even improve vision.

One study found that CXL effectively stops the progression of pellucid marginal degeneration, with most patients experiencing stable or improved vision. Another study noted that performing the procedure with the outer layer of the cornea intact results in less pain, a lower risk of infection or scarring, and a quicker return to normal activities like wearing contact lenses.

While most patients do well with just one treatment, a few might need a second round. Overall, evidence suggests that CXL is well-tolerated with few serious side effects, making it a promising option for those with these corneal conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about corneal crosslinking for keratoconus because it offers a new way to strengthen the cornea using a combination of riboflavin (vitamin B2) and ultraviolet (UV) light. Unlike standard treatments like glasses, contact lenses, or corneal transplants, this method aims to halt the progression of keratoconus rather than just manage symptoms. The unique approach involves applying a special riboflavin solution and then exposing the cornea to UV light, which helps to create new crosslinks between collagen fibers, effectively stiffening the cornea. This could mean a less invasive and potentially more effective option for patients compared to traditional surgical interventions.

What evidence suggests that Corneal Cross Linking is effective for treating keratoconus?

Research has shown that corneal cross-linking (CXL) effectively treats eye conditions such as keratoconus, pellucid marginal degeneration, and post-LASIK ectasia. Studies have found that CXL can halt the progression of these conditions, often resulting in improved or stable vision. Specifically, in pellucid marginal degeneration, CXL has proven safe and successful in preventing further vision loss. In post-LASIK ectasia, CXL reliably stabilizes the cornea. This trial will investigate the effectiveness of CXL at different fluence rates, using Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm² and 18mw/cm², to determine the most effective settings for these conditions. ^{1 2 4 5 6}

Who Is on the Research Team?

Brian J McNeel, OD

Principal Investigator

McNeel Eye Center

Gregory Kent, MD

Principal Investigator

The Eye Associates

Are You a Good Fit for This Trial?

The McNeel Eye Center's study is for men and women aged 15 to 50 who have been diagnosed with keratoconus, a condition that affects the shape of the cornea. Participants should be diagnosed through topographical methods.

Inclusion Criteria

I am aged 15-50 and have been diagnosed with keratoconus.

Exclusion Criteria

Pregnancy

Inability or unwillingness to adhere to follow up protocol.

I have had a corneal transplant before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transepithelial riboflavin .25% is applied every three minutes for 30 minutes, followed by UV light irradiation at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes

1 day

1 visit (in-person)

Follow-up

Post procedural evaluation and monitoring of visual acuity and corneal topography

12 months

6 visits (in-person) at day 1, day 7, day 30, day 90, day 180, and day 365

What Are the Treatments Tested in This Trial?

Interventions

• Corneal Cross Linking

Trial Overview This trial tests Corneal Crosslinking effectiveness using UV light at different intensities (fluence rates) compared to the standard FDA-approved protocol in treating keratoconus and related conditions.

How Is the Trial Designed?

Group I: Crosslinking at different fluence rates Experimental Treatment 1 Intervention

The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.

Who Is Running the Clinical Trial?

McNeel Eye Center

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

In a case series of four keratoconus patients treated with corneal collagen cross-linking (CXL), severe complications occurred within the first month, including bacterial infections and an autoimmune response, leading to permanent corneal scarring in some cases.

While severe complications after CXL are rare, they often arise from indirect factors during the healing process, such as patient behavior and the use of bandage contact lenses, highlighting the need for improved techniques and careful postoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Complications after Corneal Collagen Cross-Linking (CXL). Blaser, F., Zweifel, S., Wiest, MRJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9487015/

Corneal Cross-Linking in Pellucid Marginal Degeneration In conclusion, the CXL is a safe and effective treatment to halt the progression of PMD, which can, in the majority of cases, lead to improved or stable vision.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4613778/

Corneal Collagen Cross-Linking for Keratoconus and Post ... The purported advantages of epi-on CXL include reduction of postoperative pain, less chance of infection or scarring, and faster return to hard contact lens use ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1572100023002491

Results of corneal collagen cross-linking in patients with ... Corneal collagen crosslinking (CXL) is a safe and effective way of stabilizing corneal ectasia induced by LASIK (post-LASIK ectasia, PLE). •. These data ...

4. clinicaloptometry.scholasticahq.com clinicaloptometry.scholasticahq.com/article/85116-update-on-corneal-crosslinking-and-topography-guided-prk-in-the-management-of-keratoconus-pellucid-marginal-degeneration-and-ectasia

Update on Corneal Crosslinking and Topography-Guided ... Progressive Ectasia27: Although the success rate with a single treatment is high, a small percentage of patients may require a retreatment.

5. nature.com nature.com/articles/s41433-022-02365-z

National survey of corneal cross-linking (CXL) practice ... The most common indications for CXL were progressive keratoconus (100%; 16/16), post-LASIK ectasia (81%; 13/16), and pellucid marginal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02921009

McNeel Eye Center Corneal Crosslinking Study This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates ...