Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

Sponsor
Glaukos Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03319082
Collaborator
(none)
200
11
99.9
18.2
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Corneal Collagen Cross-linking

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 4, 2017
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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

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).

Outcome Measures

Primary Outcome Measures

  1. Kmax [36 months]

    Change from pretreatment baseline in maximum corneal curvature

  2. BCVA [36 month]

    Change from pretreatment baseline in BCVA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Palo Alto California United States 94303
2 Chu Vision Institute, P.A. Bloomington Minnesota United States 55420
3 Vance Thompson Vision - MT Bozeman Montana United States 59718
4 Vance Thompson Vision - ND W. Fargo North Dakota United States 58078
5 Comprehensive EyeCare of Central Ohio Westerville Ohio United States 43082
6 Vantage Eye Care, LLC Bala-Cynwyd Pennsylvania United States 19004
7 Carolina Cataract & Laser Center Ladson South Carolina United States 29456
8 Slade & Baker Vision Houston Texas United States 77027
9 Hoopes Vision Draper Utah United States 84020
10 See Clearly Vision Group McLean Virginia United States 22102
11 Northwest Eye Surgeons Seattle Washington United States 98133

Sponsors and Collaborators

  • Glaukos Corporation

Investigators

  • Study Director: Kerry Stephens, Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT03319082
Other Study ID Numbers:
  • ACP-KXL-401
First Posted:
Oct 24, 2017
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2021