NCT01398852

Brief Summary

The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

13 active sites

Status
terminated

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

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 4, 2013

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

July 11, 2011

Results QC Date

December 13, 2012

Last Update Submit

June 6, 2022

Conditions

Keratoconus and Ectasia

Outcome Measures

Primary Outcomes (1)

  • Changes in Corneal Curvature

    24 MO

Study Arms (1)

CXL Treatment

EXPERIMENTAL

All eyes to be treated with riboflavin and UV light

Drug: RiboflavinDevice: VEGA UV-A Illumination System

Interventions

RiboflavinDRUG

Riboflavin is a solution that will be delivered to the treatment area

CXL Treatment
VEGA UV-A Illumination SystemDEVICE

This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

CXL Treatment

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Diagnosis of Keratoconus or Ectasia
  • Central or Inferior steepening on the Pentacam map
  • Topography consistent with Keratoconus or Ectasia
  • BSCVA 20/20 or worse
  • Removal of contact lenses for required period of time
  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow up visits

You may not qualify if:

  • For Keratoconus, a history of previous corneal surgery
  • Corneal pachymentry equal to or greater and 400
  • Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
  • A history of chemical injury or delayed healing
  • Pregnancy
  • A known sensitivity to the study medications
  • Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
  • Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Location

Woolfson Eye Institute

Atlanta, Georgia, United States

Location

Massachusetts Eye And Ear Infirmary

Boston, Massachusetts, United States

Location

Minnesota Eye Consultants

Bloomington, Minnesota, United States

Location

Laser and Corneal Surgery Assoc. PC

New York, New York, 10022, United States

Location

Mt Sinai Hospital

New York, New York, United States

Location

Pamel Vision & Laser Group

New York, New York, United States

Location

Cleveland Clinic-Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

ReVision Advanced Laser Eye Center

Columbus, Ohio, 43240, United States

Location

OSU Department of Ophthalomogy

Columbus, Ohio, United States

Location

Dell Laser Consultants

Austin, Texas, United States

Location

Slade and Baker Vision Center

Houston, Texas, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

KeratoconusDilatation, Pathologic

Interventions

Riboflavin

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 Factors

Results Point of Contact

Title
Bob Gibson
Organization
Topcon Medical Systems
RGIBSON@TOPCON.COM
(201) 599-5121

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 21, 2011

Study Start

December 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 29, 2022

Results First Posted

March 4, 2013

Record last verified: 2022-06

Locations

US(13)