Recruiting

Observational Study

Sponsor:

Glaukos Corporation

Code:

NCT03319082

Conditions

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corneal Collagen Cross-linking

Study Details

Brief 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 patients with corneal ectasia following refractive surgery.

Conditions

Corneal Ectasia

Study ID

NCT03319082

Start date

Oct 4, 2017

Status verified date

Feb, 2024

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be at least 18 years of age, male or female, of any race;
2. Provide written informed consent and sign a HIPAA form;
3. Willingness and ability to follow all instructions and comply with schedule for study visits;
4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
5. 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);
6. 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.

Exclusion Criteria:

1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
2. The Investigator may exclude or discontinue any patient for any sound medical reason.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Corneal Collagen Cross-linking

Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).

Primary outcome measure

  • Kmax [ Time Frame: 36 months ]
  • BCVA [ Time Frame: 36 month ]

Central Contacts and Locations

Central contacts

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94303

Contacts

Principal Investigator:

Edward Manche, MD

Chu Vision Institute, P.A.

Recruiting

Bloomington, Minnesota, United States, 55420

Contacts

Principal Investigator:

Ralph Chu, MD

Vance Thompson Vision - MT

Recruiting

Bozeman, Montana, United States, 59718

Contacts

Principal Investigator:

Russell Swan, MD

Vance Thompson Vision - ND

Recruiting

W. Fargo, North Dakota, United States, 58078

Contacts

Principal Investigator:

Michael Greenwood, MD

Comprehensive EyeCare of Central Ohio

Recruiting

Westerville, Ohio, United States, 43082

Contacts

Principal Investigator:

Kenneth Beckman, MD

Vantage Eye Care, LLC

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Contacts

Principal Investigator:

Brandon Ayres, MD

Carolina Cataract & Laser Center

Recruiting

Ladson, South Carolina, United States, 29456

Contacts

Principal Investigator:

David Vroman, MD

Slade & Baker Vision

Recruiting

Houston, Texas, United States, 77027

Contacts

Principal Investigator:

Stephen Slade, MD

Hoopes Vision

Recruiting

Draper, Utah, United States, 84020

Contacts

Principal Investigator:

Majid Moshirfar, MD

See Clearly Vision Group

Recruiting

McLean, Virginia, United States, 22102

Contacts

Principal Investigator:

Christine Tagayun, MD

Northwest Eye Surgeons

Recruiting

Seattle, Washington, United States, 98133

Contacts

Principal Investigator:

Audrey Rostov, MD

More Information

Sponsor

Glaukos Corporation

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2024-02-23.