Recruiting
Phase 1

Collagen Cross-Linking

Sponsor:

Robert Mack, M.D.

Code:

NCT02009709

Conditions

Keratoconus

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Riboflavin 0.1% ophthalmic solution

CCL-VARIO UV lamp

CCL-VARIO at 18 mW/cm2

Study Details

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.

Conditions

Keratoconus

Corneal Ectasia

Study ID

NCT02009709

Start date

Oct, 2013

Status verified date

Dec, 2015

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 9 mW/cm2

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

active comparator: 18 mW/cm2

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

Interventions

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.

CCL-VARIO UV lamp

Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes

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.

Primary outcome measure

  • Decrease in maximum corneal curvature [ Time Frame: 3 and 6 months post-procedure ]

Central Contacts and Locations

Central contacts

Robert J Mack, M.D.

847-755-9393rjsmack@aol.com

Locations

Mack Eye Center

Recruiting

Hoffman Estates, Illinois, United States, 60169

Contacts

Principal Investigator:

Robert J Mack, M.D.

More Information

Sponsor

Robert Mack, M.D.

Last update posted

Dec 14, 2015

Last verified

Dec, 2015

Keywords

  • keratoconus
  • collagen crosslinking
  • crosslinking
  • ectasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Robert Mack, M.D. on 2015-12-14.