NCT01081561

Brief Summary

This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 2, 2018

Status Verified

December 1, 2017

Enrollment Period

11.9 years

First QC Date

March 4, 2010

Last Update Submit

October 1, 2018

Conditions

KeratoconusEctasia

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of UV-X cross linking to halt progression of keratoconus

    Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry

    10 years

Study Arms (2)

Cross-linking

ACTIVE COMPARATOR

Corneal collagen cross-linking with riboflavin and UVA light

Drug: Riboflavin

Cross-linking plus INTACS

ACTIVE COMPARATOR

Corneal collagen cross-linking with riboflavin and UVA light plus INTACS

Drug: Riboflavin

Interventions

RiboflavinDRUG

Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.

Also known as: Peschke Meditrade
Cross-linkingCross-linking plus INTACS

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • progressive keratoconus or ectasia

You may not qualify if:

  • cornea thinner than 400um
  • K readings greater than 60D
  • Central corneal scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornea Eye Institute, 50 North La Cienaga Blvd, #340

Beverly Hills, California, 90211, 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

Study Officials

  • Yaron S Rabinowitz, M.D.

    Cornea Genetic Eye Institute

    PRINCIPAL INVESTIGATOR

  • Ezra Maguen, M.D.

    american eye institute

    PRINCIPAL INVESTIGATOR

  • Yuri Oleynikov, M.D. PhD

    Cornea Genetic Eye Institute

    PRINCIPAL INVESTIGATOR

  • James Salz, M.D.

    Laser Eye Associates

    PRINCIPAL INVESTIGATOR

  • Ronald Gaster, MD

    Cornea Eye Institute, Beverly Hills

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Yaron S Rabinowitz M.D.

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

January 21, 2009

Primary Completion

December 30, 2020

Study Completion

June 30, 2021

Last Updated

October 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)