NCT01956474

Brief Summary

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,324

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

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

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2017

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4.1 years

First QC Date

September 27, 2013

Last Update Submit

October 10, 2018

Conditions

Keratoconus

Keywords

keratoconuscross-linkingPost-LASIK ectasiaPellucid marginal degenerationForme fruste pellucid marginal degenerationFFKCRadial KeratotomyTerrien's Marginal Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change in Best Spectacle Corrected Visual Acuity (BSCVA)

    6-9 months

Secondary Outcomes (5)

  • Change in Uncorrected Visual Acuity (UCVA)

    6-9 months

  • Change in Corneal topography

    6-9 months

  • Change in Manifest Refraction

    6-9 months

  • Change in Keratometry on topography and Pentacam

    6-9 months

  • Change in Wavefront Refraction and aberrations

    6-9 months

Study Arms (1)

Theralight crosslinking and Riboflavin

OTHER

ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin

Other: Theralight crosslinking and Riboflavin

Interventions

Theralight crosslinking and RiboflavinOTHER

Corneal Collagen cross linking with UV light and riboflavin

Theralight crosslinking and Riboflavin

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Having at least one of the following conditions:
  • Keratoconus
  • Post-LASIK ectasia
  • Pellucid marginal degeneration
  • Forme fruste pellucid marginal degeneration
  • FFKC
  • History of Radial Keratotomy with fluctuating vision.
  • Terrien's Marginal Degeneration
  • Signed written informed consent and/or assent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

You may not qualify if:

  • Severe corneal scarring that markedly affects vision
  • Contraindications to any study medications or their components
  • Pregnancy or breast feeding
  • Active Herpes Corneal Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

Stulting Research Center at Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

Location

TLC Laser Eye Center

Rockville, Maryland, 20852, United States

Location

Talamo Hatch Laser Eye Consultants, LLC

Boston, Massachusetts, 02451, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

TLC Laser Eye Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Officials

  • William Trattler, MD

    Cxlusa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 8, 2013

Study Start

January 1, 2013

Primary Completion

February 3, 2017

Study Completion

February 3, 2017

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

US(6)