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

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

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 Overview

• Status: Unknown
• Conditions: Keratoconus; Corneal Ectasia
• Intervention / Treatment: Drug: Riboflavin 0.1% ophthalmic solution; Device: CCL-VARIO UV lamp; Device: CCL-VARIO at 18 mW/cm2

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Robert J Mack, M.D.; Phone Number: 847-755-9393; Email: rjsmack@aol.com

Study Locations

• United States
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Recruiting
      • Mack Eye Center
      • Contact: Adam Baruch; Phone Number: 847-755-9393; Email: adam@mackeyecenter.com
      • Principal Investigator: Robert J Mack, M.D.
      • Sub-Investigator: Monica Kurzawa, OD
      • Sub-Investigator: Puja Shah, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 9 mW/cm2; CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution	Drug: Riboflavin 0.1% ophthalmic solution; 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.; Other Names: CXL; CCL; crosslinking; Device: CCL-VARIO UV lamp; Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes; Other Names: CXL; CCL; crosslinking
Active Comparator: 18 mW/cm2; CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution	Drug: Riboflavin 0.1% ophthalmic solution; 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.; Other Names: CXL; CCL; crosslinking; Device: CCL-VARIO at 18 mW/cm2; Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.; Other Names: CXL; CCL; crosslinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in maximum corneal curvature	3 and 6 months post-procedure

Collaborators and Investigators

• Sponsor: Robert Mack, M.D.
• Investigators: Principal Investigator: Robert J Mack, M.D., Mack Eye Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: keratoconus; ectasia; collagen crosslinking; crosslinking
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Corneal Diseases; Keratoconus; Dilatation, Pathologic; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Pharmaceutical Solutions; Ophthalmic Solutions; Riboflavin
• Other Study ID Numbers: MEC-0001