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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new treatment for keratoconus, a disease that causes the cornea to become thin and misshapen. The new treatment, called corneal cross-linking, involves using a special solution and light to strengthen the cornea.

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with keratoconus.
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I can keep my eyes fixed on one point without moving.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Topography
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
65 Previous Clinical Trials
8,890 Total Patients Enrolled
9 Trials studying Keratoconus
1,013 Patients Enrolled for Keratoconus

Media Library

NXL Energy 1 (Corneal Cross-linking) Clinical Trial Eligibility Overview. Trial Name: NCT05314738 — Phase 1 & 2
Keratoconus Research Study Groups: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B, Placebo Group 2 / Cohort 2B
Keratoconus Clinical Trial 2023: NXL Energy 1 Highlights & Side Effects. Trial Name: NCT05314738 — Phase 1 & 2
NXL Energy 1 (Corneal Cross-linking) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05314738 — Phase 1 & 2
Keratoconus Patient Testimony for trial: Trial Name: NCT05314738 — Phase 1 & 2
~32 spots leftby Jan 2025
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