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

Corneal Ectasia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03319082
Study type Observational [Patient Registry]
Source Glaukos Corporation
Contact Kerry Stephens, OD
Phone 949-481-8057
Email kstephens@glaukos.com
Status Recruiting
Phase
Start date October 4, 2017
Completion date February 2026
View Details
See also
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Completed NCT04405882 - Cornea Ectasia Excimer Laser Treatment
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Active, not recruiting NCT04763785 - Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images
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Recruiting NCT04401865 - Safety and Effectiveness of the PXL-Platinum 330 System Phase 1/Phase 2
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Completed NCT04475900 - Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics
Recruiting NCT05027295 - Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light Phase 3
Completed NCT03913338 - Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia N/A
Terminated NCT01459679 - Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery Phase 3
Withdrawn NCT01643252 - Safety and Efficacy Study for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery Phase 3
Active, not recruiting NCT04698590 - Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism N/A
Completed NCT04177082 - Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution Phase 1
Recruiting NCT06347900 - Corneal Topographic Changes in Different Grades of OSA
Completed NCT06348368 - Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder