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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:October 4, 2017
End Date:July 2023
Contact:Gerry Lohan
Email:glohan@avedro.com
Phone:7818957832

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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.

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.

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.
We found this trial at
7
sites
3900 Essex Lane
Houston, Texas 77027
Principal Investigator: Stephen Slade, MD
Phone: 713-626-5544
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501 Belmont Avenue
Bala-Cynwyd, Pennsylvania 19004
Principal Investigator: Brandon Ayres, MD
Phone: 484-434-2706
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Bloomington, Minnesota 55420
Principal Investigator: Ralph Chu, MD
Phone: 952-835-1235
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Draper, Utah 84020
Principal Investigator: Majid Moshirfar, MD
Phone: 801-568-0200
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McLean, Virginia 22102
Principal Investigator: Khoa D Hoang, MD
Phone: 703-827-4125
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Palo Alto, California 94304
Principal Investigator: Edward Manche, MD
Phone: 650-498-4573
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450 Alkyre Run Drive
Westerville, Ohio 43082
Principal Investigator: Kenneth Beckman, MD
Phone: 614-890-5692
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