NCT02009709

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

December 9, 2013

Last Update Submit

December 10, 2015

Conditions

KeratoconusCorneal Ectasia

Keywords

keratoconuscollagen crosslinkingcrosslinkingectasia

Outcome Measures

Primary Outcomes (1)

  • Decrease in maximum corneal curvature

    3 and 6 months post-procedure

Study Arms (2)

9 mW/cm2

ACTIVE COMPARATOR

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

Drug: Riboflavin 0.1% ophthalmic solutionDevice: CCL-VARIO UV lamp

18 mW/cm2

ACTIVE COMPARATOR

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

Drug: Riboflavin 0.1% ophthalmic solutionDevice: CCL-VARIO at 18 mW/cm2

Interventions

Riboflavin 0.1% ophthalmic solutionDRUG

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.

Also known as: CXL, CCL, crosslinking
18 mW/cm29 mW/cm2
CCL-VARIO UV lampDEVICE

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

Also known as: CXL, CCL, crosslinking
9 mW/cm2
CCL-VARIO at 18 mW/cm2DEVICE

Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.

Also known as: CXL, CCL, crosslinking
18 mW/cm2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prospective subjects must meet all of the following criteria to be eligible for participation:
  • 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
  • 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
  • Prospective subjects must meet the following criteria:
  • History of having undergone a keratorefractive procedure
  • +7 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mack Eye Center

Hoffman Estates, Illinois, 60169, United States

RECRUITING

MeSH Terms

Conditions

KeratoconusDilatation, Pathologic

Interventions

RiboflavinOphthalmic SolutionsChromatin Immunoprecipitation Sequencing

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsChromatin ImmunoprecipitationGenetic TechniquesInvestigative TechniquesHigh-Throughput Nucleotide SequencingSequence AnalysisSequence Analysis, DNAImmunoprecipitationImmunologic Techniques

Study Officials

  • Robert J Mack, M.D.

    Mack Eye Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Mack, M.D.

CONTACT

847-755-9393rjsmack@aol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(1)