Clinical trial NCT03319082: Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Ectasia
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kmax
timeFrame: 36 months
measure: BCVA
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Bloomington
country: United States
facility: Chu Vision Institute, P.A.
state: Minnesota
city: Bozeman
country: United States
facility: Vance Thompson Vision - MT
state: Montana
city: W. Fargo
country: United States
facility: Vance Thompson Vision - ND
state: North Dakota
city: Westerville
country: United States
facility: Comprehensive EyeCare of Central Ohio
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Vantage Eye Care, LLC
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
city: McLean
country: United States
facility: See Clearly Vision Group
state: Virginia
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens
role: STUDY_DIRECTOR
References:
citation: 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.