Corneal EctasiaCXLNCT03319082
Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
An observational study of Corneal Ectasia, run by Glaukos Corporation at 11 sites in United States.
Trial summary
The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- Corneal Collagen Cross-linking
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Oct 2017to Feb 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with corneal ectasia following refractive surgery who are planning to undergo or have undergone corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information.
Who may be able to join
- Be at least 18 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form;
- Willingness and ability to follow all instructions and comply with schedule for study visits;
- Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
- Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to enrolling in the registry; must not be pregnant or lactating.
Who cannot join
- If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
- The Investigator may exclude or discontinue any patient for any sound medical reason.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Vantage Eye Care, LLC
Bala-Cynwyd, Pennsylvania, 19004
Gwen Toti, 484-434-2706, gtoti@oppdoctors.com
Brandon Ayres, MD
- Recruiting
Chu Vision Institute, P.A.
Bloomington, Minnesota, 55420
Nic Jacobs, 952-835-1235 ext. 205, nic.jacobs@chuvision.com
Ralph Chu, MD
- Recruiting
Vance Thompson Vision - MT
Bozeman, Montana, 59718
Briana Parker, 406-219-0700, briana.parker@vancethompsonvision.com
Russell Swan, MD
- Recruiting
Hoopes Vision
Draper, Utah, 84020
Michele Avila, OD, 801-568-0200, mavila@hoopesvision.com
Majid Moshirfar, MD
- Recruiting
Slade & Baker Vision
Houston, Texas, 77027
Beverly Socop, 713-626-5544, beverly@visiontexas.com
Stephen Slade, MD
- Recruiting
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Margaret Bozic, 843-797-3676, mbozic@carolinacataract.com
David Vroman, MD
- Recruiting
See Clearly Vision Group
McLean, Virginia, 22102
Claire Thomas, 703-827-5454, cthomas@seeclearly.com
Christine Tagayun, MD
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94303
Theresa Enriquez, COT, 650-498-4573, Tenriquez@stanfordhealthcare.org
Edward Manche, MD
- Recruiting
Northwest Eye Surgeons
Seattle, Washington, 98133
Claire Callaghan, 206-528-6000, ccallaghan@nweyes.com
Audrey Rostov, MD
- Recruiting
Vance Thompson Vision - ND
West Fargo, North Dakota, 58078
Sarah Thiede, 701-566-5390, sarah.thiede@vancethompsonvision.com
Michael Greenwood, MD
- Recruiting
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, 43082
Donna Coury, 614-890-5692, dcoury@compeyecare.com
Kenneth Beckman, MD
About this study
Official title: A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery
The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
Read the detailed description
Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.
- Conditions
- Corneal Ectasia
- Being tested
- Corneal Collagen Cross-linking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Collagen Cross-linkingCombination product
Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).
| Study group | Role | What they receive |
|---|---|---|
| CXL Group | Patients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information Receives: Combination Product: Corneal Collagen Cross-linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kmax
Change from pretreatment baseline in maximum corneal curvature
Measured: 36 months
BCVA
Change from pretreatment baseline in BCVA
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start4 Oct 2017
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Stephens, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319082
- Sponsor's protocol ID
- ACP-KXL-401
- Acronym
- CXL
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2017
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24.
PubMed 28655538
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery
- ClinicalTrials.gov ID
- NCT03319082
- Acronym / sponsor ID
- CXL / ACP-KXL-401
- Conditions
- Corneal Ectasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
Detailed description
Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXL Group | – | Combination Product: Corneal Collagen Cross-linkingPatients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with corneal ectasia following refractive surgery who are planning to undergo or have undergone corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information.
Key inclusion criteria (6 listed)
- Be at least 18 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form;
- Willingness and ability to follow all instructions and comply with schedule for study visits;
- Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
- Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
Key exclusion criteria (2 listed)
- If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
- The Investigator may exclude or discontinue any patient for any sound medical reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Collagen Cross-linkingPhotrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation). | Combination product | CXL Group |
Primary outcome
Kmax
Time frame: 36 months
Change from pretreatment baseline in maximum corneal curvature
BCVA
Time frame: 36 month
Change from pretreatment baseline in BCVA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 28655538Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24.
- U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
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Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
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RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry Stephens study director
Glaukos Corporation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia, run by Glaukos Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerry Stephens, OD (949-481-8057, kstephens@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kmax (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.