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Clinical Trials/NCT02009709
NCT02009709
Unknown
Phase 1

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia

Robert Mack, M.D.1 site in 1 country100 target enrollmentOctober 2013
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ConditionsKeratoconusCorneal Ectasia
InterventionsRiboflavin 0.1% ophthalmic solutionCCL-VARIO UV lampCCL-VARIO at 18 mW/cm2
DrugsRiboflavin 0.1% ophthalmic solution

Overview

Phase
Phase 1
Intervention
Riboflavin 0.1% ophthalmic solution
Conditions
Keratoconus
Sponsor
Robert Mack, M.D.
Enrollment
100
Locations
1
Primary Endpoint
Decrease in maximum corneal curvature
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
January 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Robert Mack, M.D.
Responsible Party
Sponsor Investigator
Principal Investigator

Robert Mack, M.D.

Sponsor-Investigator

Mack Eye Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

9 mW/cm2

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

Intervention: Riboflavin 0.1% ophthalmic solution

9 mW/cm2

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

Intervention: CCL-VARIO UV lamp

18 mW/cm2

CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution

Intervention: Riboflavin 0.1% ophthalmic solution

18 mW/cm2

CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution

Intervention: CCL-VARIO at 18 mW/cm2

Outcomes

Primary Outcomes

Decrease in maximum corneal curvature

Time Frame: 3 and 6 months post-procedure

Study Sites (1)

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