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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01398839
Other study ID # CXL-002
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2010
Est. completion date July 2012

Study information

Verified date June 2022
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.


Recruitment information / eligibility

Status Terminated
Enrollment 103
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 Years of age or older - Diagnosis of Ectasia - Presence of central or inferior steepening - Topography consistent with ectasia - BSCVA 20/20 or worse - If contact lens wearer; removal of contact lenses for required period of time - Signed informed consent - Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: - Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision - History of chemical injury or delayed epithelial healing - A known sensitivity to study medications - Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests - A condition that would interfere with or prolong epithelial healing - Presence or history of any other condition or finding that makes the patient unsuitable for treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light
Drug:
Riboflavin
Both treatment and sham groups will receive riboflavin

Locations

Country Name City State
United States Woolfson Eye Institute Atlanta Georgia
United States Dell Laser Consultants Austin Texas
United States Minnesota Eye Consultants, P.A. Bloomington Minnesota
United States Cleveland Clinic-Cole Eye Institute Cleveland Ohio
United States ReVision Advanced Laser Eye Center Columbus Ohio
United States The Ohio State University College of Medicine Columbus Ohio
United States Slade & Baker Vision Houston Texas
United States Laser and Corneal Surgery Assoc. PC New York New York
United States Mt. Sinai Hospital New York New York
United States Pamel Vision & Laser Group New York New York
United States Barnet Dulaney Perkins Eye Center Phoenix Arizona
United States The Eye Institute of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Corneal Curvature 6 Months
See also
  Status Clinical Trial Phase
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Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Terminated NCT01024322 - Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Not yet recruiting NCT03858036 - Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders Phase 3
Completed NCT02131740 - Eye Rubbing and Transient Change in Corneal Parameters N/A
Recruiting NCT01325298 - UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia Phase 2
Completed NCT00592644 - Laser Treatment Of Vascular Lesions On Vocal Cords Phase 2
Active, not recruiting NCT03080077 - Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia Phase 3
Recruiting NCT02118922 - A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Enrolling by invitation NCT01081561 - Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs Phase 2/Phase 3
Completed NCT00004327 - Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia Phase 2
Terminated NCT01189864 - Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
Completed NCT00674661 - Corneal Collagen Cross-Linking for Ectasia (CXL) Phase 3
Completed NCT04649177 - Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting N/A
Completed NCT03896321 - Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management N/A
Terminated NCT01097447 - Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
Completed NCT02008253 - Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel) N/A
No longer available NCT01384773 - Progressive Keratoconus or Ectasia Treatment Plan