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NCT00567671 Clinical Trial

Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Corneal Ectasia Clinical Trial

— CL  

Official title:
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00567671
Other study ID # UVX-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 3, 2007
Last updated September 1, 2010
Start date December 2007
Est. completion date June 2010

Study information
Verified date July 2009
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Description:

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.

Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of keratoconus with documented progression over the previous 12 months.

- Diagnosis of corneal ectasia

- Must be able to complete all study visits

Exclusion Criteria:

- Prior corneal surgery in the keratoconus group

- Corneal scarring

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Corneal collagen
Corneal collagen cross-linking with riboflavin/UVA light
• Sham comparator
Sham treatment

Locations
Country Name City State
United States Woolfson Eye Institute Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in keratometry 3 Months
Secondary Best spectacle-corrected visual acuity 3 Months
See also
  Status Clinical Trial Phase
Recruiting NCT03319082 - Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
Recruiting NCT02009709 - Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 Phase 1
Recruiting NCT04094090 - Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia Phase 2
Completed NCT04405882 - Cornea Ectasia Excimer Laser Treatment
Active, not recruiting NCT01464268 - Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia Phase 3
Active, not recruiting NCT04763785 - Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images
Recruiting NCT01325298 - UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia Phase 2
Recruiting NCT04251143 - Dresden Corneal Disease and Treatment Study
Active, not recruiting NCT01152541 - Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin Phase 3
Recruiting NCT04905108 - Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia Phase 3
Recruiting NCT04401865 - Safety and Effectiveness of the PXL-Platinum 330 System Phase 1/Phase 2
Completed NCT05691335 - Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus N/A
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

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