NCT00435799

Brief Summary

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

February 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 10, 2008

Status Verified

January 1, 2007

Enrollment Period

1.9 years

First QC Date

February 13, 2007

Last Update Submit

June 9, 2008

Conditions

Keratoconus

Keywords

keratoconuscorneal cross-linkingriboflavineultraviolet type A rays (UVA)

Outcome Measures

Primary Outcomes (3)

  • 1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.

  • 2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).

  • 3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).

Study Arms (1)

A

ACTIVE COMPARATOR
Procedure: corneal cross-linking (CCL)Drug: Riboflavin/dextran eyedropsDevice: UV-X system

Interventions

corneal cross-linking (CCL)PROCEDURE
Also known as: Riboflavine, UVX
A
Riboflavin/dextran eyedropsDRUG
A
UV-X systemDEVICE
A

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20 to 45 years
  • Progressive keratectasia (primary or secondary) in an advanced stage
  • Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses
  • Rigid contact lenses are either not tolerated or do not improve visual acuity
  • No previous eye surgery (except for laser refractive surgery)
  • All patients must provide written informed consent to become a study subject
  • Subjects able to return for scheduled follow-up examinations according to this protocol

You may not qualify if:

  • Corneal thickness \< 400 µm at thinnest position
  • Keratometric - readings above 60 diopters
  • Other active ocular disease than keratectasia
  • Herpes keratitis
  • Previous ocular surgery (other than laser refractive surgery)
  • Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease
  • Patients with known sensitivity to study medication
  • Subjects with intraocular pressure \> 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects
  • Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eye dpt, Ullevål University Hospital

Oslo, Oslo County, N-0407, Norway

RECRUITING

Eye dpt, University Hospital North Norway

Tromsø, Tromsø, No-9037, Norway

RECRUITING

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-LinkingRiboflavin

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Aleksandar Stojanovic, MD

    Eye dpt, University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ALEKSANDAR STOJANOVIC, MD

CONTACT

+47 77 64 79 20aleks@online.no

ESPEN F BAKKE, MD

CONTACT

+47 22118545espen.bakke@medisin.uio.no

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 15, 2007

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2010

Last Updated

June 10, 2008

Record last verified: 2007-01

Locations

NO(2)