What is the mechanism of action of this treatment?

Corneal Cross-linking (CXL) is a primary treatment for Keratoconus that involves applying riboflavin (vitamin B2) to the cornea and then exposing it to ultraviolet A (UVA) light. This process creates new cross-links between collagen fibers, strengthening and stabilizing the corneal structure. For Keratoconus patients, this is vital as it halts the progression of the disease, which causes the cornea to thin and bulge, leading to distorted vision. By reinforcing the corneal collagen, CXL can prevent further deterioration and improve visual outcomes.

What side effects are associated with this type of intervention?

Corneal Cross-linking (CXL) for Keratoconus, which involves the use of riboflavin and UVA light to strengthen corneal collagen fibers, commonly results in transient discomfort, corneal haze, and temporary vision disturbances. More serious but rare complications can include corneal infection, scarring, and endothelial cell damage. These side effects are generally manageable and the procedure is considered safe and effective for halting the progression of Keratoconus.

What prior FDA approvals exist?

The FDA has approved corneal cross-linking as a treatment for Keratoconus. This procedure involves the application of riboflavin (vitamin B2) eye drops to the cornea, followed by exposure to UVA light. The combination of riboflavin and UVA light strengthens the collagen fibers in the cornea, thereby stabilizing the corneal structure and halting the progression of Keratoconus. This treatment is specifically designed to address the weakening of the corneal tissue that characterizes Keratoconus.

What other types of research exist?

Promising novel alternatives to Corneal Cross-linking for Keratoconus patients include: 1) Intrastromal Corneal Ring Segments (ICRS), which involve implanting small rings in the cornea to flatten it and improve vision; 2) Topography-guided Photorefractive Keratectomy (PRK) combined with CXL, which reshapes the cornea and strengthens it simultaneously; 3) Customized Corneal Cross-linking, which tailors the treatment to the specific corneal topography of the patient; and 4) Gene therapy approaches targeting the underlying genetic causes of Keratoconus, though these are still largely experimental.

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Corneal Cross-linking

Corneal Cross-Linking for Keratoconus

Phase 1 & 2

Recruiting

Research Sponsored by Glaukos Corporation

Eligibility Criteria Checklist

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

Must have

Have a diagnosis of keratoconus

Ability to hold gaze sufficiently stable for study testing

Must not have

Any disease causing abnormal topography other than keratoconus

Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is testing a treatment that uses light and vitamins to strengthen the cornea in people with keratoconus, a condition that makes the cornea thin and cone-shaped. The new treatment option aims to improve the cornea's strength and shape.

Who is the study for?

This trial is for individuals with keratoconus, a condition that affects the shape of the cornea. Participants must be able to keep their gaze stable and give written consent. It's not open to those with other diseases affecting eye topography, prior eye conditions that could complicate results, or allergies to components used in the treatments.

What is being tested?

The study tests three different energy levels (NXL Energy 1, NXL Energy 2, NXL Energy 3) of corneal cross-linking against a sham treatment to see which is safest and most effective at stabilizing the cornea in keratoconus patients.

What are the potential side effects?

While specific side effects are not listed here, typical risks from corneal cross-linking may include temporary visual disturbances, discomfort or pain in the eye, potential infection risk and rarely long-term changes in vision.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with keratoconus.

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I can keep my eyes fixed on one point without moving.

Exclusion Criteria

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

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I have an eye condition that is not keratoconus.

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I have an eye condition that could lead to future problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Topography

Secondary study objectives

Distance Uncorrected Visual Acuity (UCVA)

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1Experimental Treatment1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group II: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2AActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

Group III: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2AActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

Group IV: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2AActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group V: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2BActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

Group VI: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2BActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

Group VII: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2BActive Control1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group VIII: Placebo Group 2 / Cohort 2BPlacebo Group1 Intervention

Sham Solution with no exposure to NXL System

0 / 4Eligibility 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

Corneal Cross-linking (CXL) is a primary treatment for Keratoconus that involves applying riboflavin (vitamin B2) to the cornea and then exposing it to ultraviolet A (UVA) light. This process creates new cross-links between collagen fibers, strengthening and stabilizing the corneal structure. For Keratoconus patients, this is vital as it halts the progression of the disease, which causes the cornea to thin and bulge, leading to distorted vision. By reinforcing the corneal collagen, CXL can prevent further deterioration and improve visual outcomes.