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NCT00679666 Clinical Trial

Corneal Crosslinking in Keratoconus and Corneal Ectasia

Corneal Ectasia Clinical Trial

— CXL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00679666
Other study ID # 2008H0050,2008H0049
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received April 2, 2008
Last updated April 18, 2017
Start date April 2008
Est. completion date October 2010

Study information
Verified date April 2017
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 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 keratoconus group

- Corneal scarring

- Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Riboflavin
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
• Placebo
Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.

Locations
Country Name City State
United States The Ohio State University Medical Center Columbus Ohio
United States OSU Havener Eye Institute Dublin Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State 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
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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