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Completed

NCT Number: NCT00567671

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

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.

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Key information

Conditions

Progressive Keratoconus Corneal Diseases Corneal Ectasia Dilatation, Pathologic Eye Diseases Keratoconus Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal collagen

Procedure

Corneal collagen cross-linking with riboflavin/UVA light

Sham Comparator

Procedure

Sham treatment

Primary outcomes

  1. Change in keratometry

    Time frame: 3 Months

Secondary outcomes

  1. Best spectacle-corrected visual acuity

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: CL

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2007
Registry last updated
Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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