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

100 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.

What data supports the effectiveness of the treatment Corneal Cross Linking for Keratoconus?

Research shows that corneal cross-linking can improve vision and stabilize the cornea in people with progressive keratoconus, a condition where the cornea becomes thin and cone-shaped. Studies comparing different methods of this treatment have found positive outcomes in terms of vision and corneal stability over time. ^{1 2 3 4 5}

Is corneal cross-linking safe for treating keratoconus?

Corneal cross-linking is generally considered safe, with studies showing it has a high safety profile. However, rare severe complications like corneal melting and scarring have been reported, especially if the cornea is thinner than recommended. ^{6 7 8 9 10}

How is corneal crosslinking treatment different from other treatments for keratoconus?

Corneal crosslinking is unique because it is the only treatment that can stop the progression of keratoconus by strengthening the cornea using riboflavin (a type of vitamin B2) and UV-A light. Unlike other treatments, it can be performed without removing the corneal surface, which may reduce pain after the procedure. ^{11 12 13 14 15}

What is the purpose of this trial?

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Research Team

Brian J McNeel, OD

Principal Investigator

McNeel Eye Center

Gregory Kent, MD

Principal Investigator

The Eye Associates

Eligibility Criteria

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

I have had a corneal transplant before.

Pregnancy

Inability or unwillingness to adhere to follow up protocol.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Intraoperative and postoperative effects of corneal collagen cross-linking on progressive keratoconus. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Different accelerated corneal collagen cross-linking treatment modalities in progressive keratoconus. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison Between Pulsed and Continuous Accelerated Corneal Cross-Linking Protocols. [2023]

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

Safety, Efficacy, and Predictive Factors of Conventional Epithelium-Off Corneal Crosslinking in the Treatment of Progressive Keratoconus. [2022]

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

Personalized Model to Predict Keratoconus Progression From Demographic, Topographic, and Genetic Data. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Corneal melting after collagen cross-linking for keratoconus: a case report. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Severe Complications after Corneal Collagen Cross-Linking (CXL). [2023]

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

Long-term Safety and Efficacy of Corneal Collagen Crosslinking in a Pediatric Group With Progressive Keratoconus: A 7-year Follow-up. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Corneal melting in both eyes after simultaneous corneal cross-linking in a patient with keratoconus and Down syndrome]. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Corneal Cross-Linking in Patients Affected by Keratoconus: Long-Term Results. [2023]

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

Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: ten-year results. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Corneal collagen crosslinking for progressive keratoconus in Saudi Arabia: One-year controlled clinical trial analysis. [2022]

13. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of Two Different Accelerated Corneal Cross-linking Procedure Outcomes in Patients with Keratoconus [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

[Crosslinking and Keratoconus]. [2021]

15. India pubmed.ncbi.nlm.nih.gov

Comparative study of changes of corneal curvatures and uncorrected distance visual acuity prior to and after corneal collagen crosslinking: 1-year results. [2020]