Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

Brief Title

Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

Official Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Decrease in maximum corneal curvature

Condition

Keratoconus

Intervention

Riboflavin 0.1% ophthalmic solution

Study Arms / Comparison Groups

 9 mW/cm2

Description:  CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

October 2013

Primary Completion Date

January 2017

Eligibility Criteria

        General Inclusion Criteria

        Prospective subjects must meet all of the following criteria to be eligible for
        participation:

          -  18 years of age or older

          -  Signed written informed consent

          -  Willingness and ability to comply with schedule for follow-up visits

          -  Contact lens removal prior to evaluation and treatment

        Inclusion criteria for progressive keratoconus

        Prospective subjects must meet two of the following criteria:

          -  Having a diagnosis of progressive keratoconus:

          -  An increase of ≥ 1.00 D in the steepest keratometry value

          -  An increase of ≥ 1.00 D in astigmatism manifest refraction

          -  A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective
             manifest refraction

          -  Presence of central or inferior steepening on the Pentacam map.

          -  Axial topography consistent with keratoconus

          -  Steepest keratometry (Kmax) value ≥ 47.00 D

        Inclusion criteria for ectasia

        Prospective subjects must meet the following criteria:

          -  History of having undergone a keratorefractive procedure

          -  Meeting two of the following criteria

          -  Steepening by topography, either Pentacam or Humphrey

          -  Thinning of cornea

          -  Shift in the position of thinnest portion of cornea

          -  Change in refraction with increasing myopia

          -  Development of myopic astigmatism

          -  Development of irregular astigmatism

          -  Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria

        Subjects meeting any of the following criteria will be excluded from this protocol:

          -  Eyes classified as either normal, atypical normal,

          -  Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye
             to be treated

          -  A history of chemical injury or delayed epithelial healing in the eye to be treated.

          -  Pregnancy (including plan to become pregnant) or lactation during the course of the
             study

          -  A known sensitivity to study medications

          -  Patients with nystagmus or any other condition that would prevent a steady gaze during
             the treatment

          -  Inability to cooperate with diagnostic tests.

          -  Patients with a current condition that, in the investigator's opinion, would interfere
             with or prolong epithelial healing.

          -  Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking
             treatment.

          -  Patients who are unable to remain supine and tolerate a lid speculum for an extended
             period of time.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Robert J Mack, M.D., 847-755-9393, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT02009709

Organization ID

MEC-0001

Responsible Party

Sponsor-Investigator

Study Sponsor

Robert Mack, M.D.

Study Sponsor

Robert J Mack, M.D., Principal Investigator, Mack Eye Center

Verification Date

December 2015