NCT00642044

Brief Summary

Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

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

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 23, 2008

Status Verified

March 1, 2008

Enrollment Period

1.8 years

First QC Date

March 17, 2008

Last Update Submit

April 22, 2008

Conditions

Keratoconus

Keywords

Keratoconus

Outcome Measures

Primary Outcomes (2)

  • Keratometry

    3 months

  • BSCVA (Best spectacle corrected visual acuity)

    3 months

Secondary Outcomes (1)

  • Endothelial cell count

    3 months

Study Arms (2)

A

EXPERIMENTAL

The eye with the worst visual acuity receives the treatment. (the other eye serve as control).

Procedure: Corneal Collagen Crosslinking

B

NO INTERVENTION

The eye with the best visual acuity do not receive the treatment.

Interventions

Corneal Collagen CrosslinkingPROCEDURE

UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.

A

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 35 years.
  • Diagnosis of Keratoconus.
  • Progression of Ametropia.
  • Written informed consent.

You may not qualify if:

  • Corneal Thickness \< 395 micra at thinnest point.
  • Other active ocular disease than keratectasia.
  • Cornea Guttata.
  • Previous ocular surgery.
  • Pregnancy.
  • Known sensitivity to riboflavin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

RECRUITING

Related Publications (7)

  • Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.

    PMID: 12719068BACKGROUND

  • Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103. doi: 10.1006/exer.1997.0410.

    PMID: 9533835BACKGROUND

  • Kolozsvari L, Nogradi A, Hopp B, Bor Z. UV absorbance of the human cornea in the 240- to 400-nm range. Invest Ophthalmol Vis Sci. 2002 Jul;43(7):2165-8.

    PMID: 12091412BACKGROUND

  • Sekundo W, Stevens JD. Surgical treatment of keratoconus at the turn of the 20th century. J Refract Surg. 2001 Jan-Feb;17(1):69-73. doi: 10.3928/1081-597X-20010101-09.

    PMID: 11201780BACKGROUND

  • Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.

    PMID: 16765803BACKGROUND

  • Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. doi: 10.1097/ICO.0b013e3180334f78.

    PMID: 17457183BACKGROUND

  • Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5. doi: 10.1016/s0886-3350(03)00407-3.

    PMID: 14522301BACKGROUND

Related Links

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Ricardo Lamy, MD

    UFRJ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Lamy, MD

CONTACT

55-21-2714-7646lamy@ufrj.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

April 23, 2008

Record last verified: 2008-03

Locations

BR(1)