An observational study in Corneal Ectasia, sponsored by Glaukos Corporation. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Glaukos Corporation · Observational
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.
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.
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.
Exclusion Criteria:
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
Combination Product: 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).
Kmax
Change from pretreatment baseline in maximum corneal curvature
Time frame: 36 months
BCVA
Change from pretreatment baseline in BCVA
Time frame: 36 month
Plan to share: No
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Glaukos Corporation