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

Primary Purpose

Keratoconus, Corneal Ectasia

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Riboflavin 0.1% ophthalmic solution
CCL-VARIO UV lamp
CCL-VARIO at 18 mW/cm2
Sponsored by
Robert Mack, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, collagen crosslinking, crosslinking, ectasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mack Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

9 mW/cm2

18 mW/cm2

Arm Description

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

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

Outcomes

Primary Outcome Measures

Decrease in maximum corneal curvature

Secondary Outcome Measures

Full Information

First Posted
December 9, 2013
Last Updated
December 10, 2015
Sponsor
Robert Mack, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02009709
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Mack, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Corneal Ectasia
Keywords
keratoconus, collagen crosslinking, crosslinking, ectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
9 mW/cm2
Arm Type
Active Comparator
Arm Description
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
Arm Title
18 mW/cm2
Arm Type
Active Comparator
Arm Description
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Riboflavin 0.1% ophthalmic solution
Other Intervention Name(s)
CXL, CCL, crosslinking
Intervention Description
Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
Intervention Type
Device
Intervention Name(s)
CCL-VARIO UV lamp
Other Intervention Name(s)
CXL, CCL, crosslinking
Intervention Description
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
Intervention Type
Device
Intervention Name(s)
CCL-VARIO at 18 mW/cm2
Other Intervention Name(s)
CXL, CCL, crosslinking
Intervention Description
Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
Primary Outcome Measure Information:
Title
Decrease in maximum corneal curvature
Time Frame
3 and 6 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert J Mack, M.D.
Phone
847-755-9393
Email
rjsmack@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Mack, M.D.
Organizational Affiliation
Mack Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mack Eye Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Baruch
Phone
847-755-9393
Email
adam@mackeyecenter.com
First Name & Middle Initial & Last Name & Degree
Robert J Mack, M.D.
First Name & Middle Initial & Last Name & Degree
Monica Kurzawa, OD
First Name & Middle Initial & Last Name & Degree
Puja Shah, OD

12. IPD Sharing Statement

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

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