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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.
Select...
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been accepted into this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this trial commenced on March 8th 2022 and was recently updated on March 29th 2022. Currently, 150 volunteers are needed at 4 distinct sites."

Answered by AI

Is the enrollment of individuals aged 35+ being considered for this clinical trial?

"The eligibility conditions for this trial state that individuals aged between 18 and 55 are able to participate. For those under the age of 18, there are a total of 18 studies available while 35 trials exist for seniors over 65 years old."

Answered by AI

Could I be qualified to participate in this medical trial?

"Aspiring enrollees need to meet two criteria: they must have progressive keratoconus and be aged between 18-55. This clinical trial is aiming to include a total of 150 participants."

Answered by AI

Is this research endeavor recruiting participants at the present time?

"Clinicaltrials.gov reveals that this research project, which was first published on March 8th 2022, is actively recruiting new participants. The post has been updated as recently as March 29th of the same year."

Answered by AI

How many distinct sites are currently hosting this investigation?

"Currently, 4 sites are running the trial. These include Boston, Dothan and Westerville as well as four other locales. To minimize traveling costs for participants, it is recommended to select the closest available medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Texas
Nevada
Other
What site did they apply to?
Glaukos Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How often am I required to travel? I’m willing to travel. Is distance going to be an issue?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am hoping this trial will help my medical condition. I can no longer see my daughters face expression from across the room.
PatientReceived no prior treatments
I want to stop the worsening of my keratoconus. I am needing to keep driving and seeing to drive.
PatientReceived no prior treatments
I’ve tried two other procedures that didn’t work and would like to try this before a cornea transplant.
PatientReceived 2+ prior treatments
I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
2022. "Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05314738.
All > Keratoconus
~36 spots leftby Jan 2025
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