NCT01726283

Brief Summary

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

November 9, 2012

Last Update Submit

August 20, 2015

Conditions

Fruste KeratoconusRisk of Ectasia

Keywords

fruste keratoconusectasia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Best-Corrected Visual Acuity

    Month 9

Secondary Outcomes (1)

  • Residual Refractive error at the 1, 3 and 6 month visits

    Months 1, 3, and 6

Study Arms (2)

low risk subjects for developing post-operative ectasia

Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia

Device: Corneal Cross-LinkingDrug: Riboflavin

Subjects at Risk for Ectasia

Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia

Device: Corneal Cross-LinkingDrug: Riboflavin

Interventions

Corneal Cross-LinkingDEVICE

Corneal cross-linking procedure conducted during vision correction surgery.

Subjects at Risk for Ectasialow risk subjects for developing post-operative ectasia
RiboflavinDRUG

Riboflavin will be instilled prior to corneal cross linking.

Subjects at Risk for Ectasialow risk subjects for developing post-operative ectasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • years of age or older
  • Up to 4 potential risk factors for ectasia
  • A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
  • B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
  • C. Age 18 to 25
  • D. Planned Residual stromal bed between 250 and 300 microns
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
  • Patients with and without previous laser vision correction are eligible for participation.

You may not qualify if:

  • Frank keratoconus, Pellucid, or Post-LASIK ectasia
  • Less than 20/30 BSCVA in either eye
  • 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 (8)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Clear View Eye & Laser Medical Center

San Diego, California, United States

Location

The Center for Excellence in Eye Care

Miami, Florida, United States

Location

TLC Laser Eye Center

Rockville, Maryland, 20852, United States

Location

Talamo Laser Eye Center

Waltham, Massachusetts, United States

Location

Minnesota Eye Consultants

Minneapolis, Minnesota, United States

Location

Cleveland Eye Clinic

Breckville, Ohio, United States

Location

TLC Laser Eye Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Corneal Cross-LinkingRiboflavin

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapyFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Officials

  • William Trattler, MD

    Center For Excellence In Eye Care

    STUDY DIRECTOR

  • Roy Rubinfeld

    CXL-USA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(8)