What side effects are associated with this type of intervention?

Corneal collagen cross-linking (CXL) is a common treatment for keratoconus that aims to strengthen corneal collagen fibers, thereby reducing corneal aberrations and improving vision. Known side effects of CXL include transient eye pain, corneal haze, and temporary vision disturbances. In some cases, patients may experience delayed epithelial healing, infection, or corneal scarring. These side effects are generally manageable and tend to resolve over time, but it is important for patients to discuss potential risks and benefits with their ophthalmologist.

What prior FDA approvals exist?

The FDA has approved corneal collagen cross-linking (CXL) for the treatment of keratoconus. This procedure involves the use of riboflavin (vitamin B2) eye drops and ultraviolet A (UVA) light to strengthen the collagen fibers in the cornea, thereby reducing corneal aberrations and improving vision. The primary FDA-approved treatment similar to the one being studied in the trial is the standard epithelium-off (epi-off) CXL procedure, which has been shown to halt the progression of keratoconus and improve corneal stability.

What other types of research exist?

Promising novel alternatives to Laser Custom Corneal Collagen Cross-linking (CXL) for Keratoconus patients include: 1) Topography-guided photorefractive keratectomy (TG-PRK) combined with CXL, which reshapes the cornea and strengthens it simultaneously. 2) Intrastromal corneal ring segments (ICRS), which are implants that help flatten the cornea and improve vision. 3) Corneal allogenic intrastromal ring segments (CAIRS), a newer technique using donor tissue to achieve similar effects as ICRS. 4) Customized contact lenses, such as scleral lenses, which provide better vision correction and comfort. 5) Gene therapy and regenerative medicine approaches, which are still in experimental stages but hold potential for future treatment.

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Procedure

Corneal Collagen Cross-Linking for Keratoconus

N/A

Recruiting

Led By David Huang, MD, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of keratoconus

Be older than 18 years old

Must not have

Mature cataracts if found to limit visual potential to worse than 20/40

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after the cxl procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special laser treatment with precise scanning and medication to improve vision in patients with keratoconus by strengthening and smoothing their corneas.

Who is the study for?

This trial is for individuals with keratoconus, a condition that affects the cornea of the eye. Participants must have a minimum corneal thickness of 410 microns and be able to commit to study visits and give informed consent. Those with mature cataracts, difficulty maintaining fixation for imaging, or other eye conditions like glaucoma are excluded.

What is being tested?

The trial is testing Laser Custom Corneal Collagen Cross-Linking (CXL), which aims to reduce corneal aberrations and improve vision in keratoconus patients. The procedure's effectiveness will be assessed using OCT-guided lasers for precision in corneal smoothing.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, temporary visual disturbances, increased sensitivity to light, dry eyes or potential worsening of vision if complications occur. However, CXL is generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with keratoconus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cataracts limit my vision to worse than 20/40.

Select...

I am unable to understand and agree to the study's details.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after the cxl procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after the cxl procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after the cxl procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in best spectacle-corrected visual acuity after laser custom CXL

Secondary study objectives

Determine CXL demarcation line depth

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SurgeryExperimental Treatment1 Intervention

OCT-guided custom laser CXL

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Laser Custom Corneal Collagen Cross-linking (CXL) is a treatment for Keratoconus that involves the use of lasers to strengthen the collagen fibers in the cornea. This process increases the rigidity of the corneal structure, thereby reducing corneal thinning and irregularities. By stabilizing the cornea, CXL helps to decrease corneal aberrations, which are distortions in the cornea that can impair vision. This is particularly important for Keratoconus patients as it can significantly improve their visual acuity and reduce the progression of the disease, leading to better overall eye health and quality of life.