NCT00832897

Brief Summary

The purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking , and after, corneal ring surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

January 29, 2009

Last Update Submit

January 6, 2011

Conditions

Keratoconus

Keywords

Keratoconusriboflavincorneacrosslinking

Outcome Measures

Primary Outcomes (1)

  • Refractive data, visual acuity, topography patterns, pachymetry measurements.

    Two years

Secondary Outcomes (1)

  • Anterior segment tomography data, corneal biomechanics, impression cytology.

    Two years

Study Arms (2)

Eyedrop

SHAM COMPARATOR
Procedure: Corneal collagen crosslinking

Crosslinking

ACTIVE COMPARATOR

The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.

Procedure: Corneal collagen crosslinking

Interventions

Corneal collagen crosslinkingPROCEDURE

The patients will be submitted to corneal collagen crosslinking, that consists: Instillation of riboflavin eyedrop in the cornea for thirty minutes, and after, the patient will stay under the Crosslinking equipment, for more thirty minutes, also receiving riboflavin eyedrop.

Also known as: Keratoconus., Corneal collagen crosslinking.
CrosslinkingEyedrop

Eligibility Criteria

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

You may qualify if:

  • Patients with keratoconus
  • Patients that aren't using contact lenses
  • Pachymetry more than 400Um
  • Best visual acuity less or equal 20/30

You may not qualify if:

  • Ocular surgeries before
  • Other eye diseases
  • Corneal curvature more than 65 dioptres

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04038-000, Brazil

Location

Related Publications (4)

  • Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8. doi: 10.1016/j.jcrs.2007.03.021.

    PMID: 17531694BACKGROUND

  • Coskunseven E, Kymionis GD, Tsiklis NS, Atun S, Arslan E, Jankov MR, Pallikaris IG. One-year results of intrastromal corneal ring segment implantation (KeraRing) using femtosecond laser in patients with keratoconus. Am J Ophthalmol. 2008 May;145(5):775-9. doi: 10.1016/j.ajo.2007.12.022. Epub 2008 Mar 4.

    PMID: 18291344BACKGROUND

  • Wollensak G, Spoerl E. Collagen crosslinking of human and porcine sclera. J Cataract Refract Surg. 2004 Mar;30(3):689-95. doi: 10.1016/j.jcrs.2003.11.032.

    PMID: 15050269RESULT

  • Renesto Ada C, Melo LA Jr, Sartori Mde F, Campos M. Sequential topical riboflavin with or without ultraviolet a radiation with delayed intracorneal ring segment insertion for keratoconus. Am J Ophthalmol. 2012 May;153(5):982-993.e3. doi: 10.1016/j.ajo.2011.10.014. Epub 2012 Jan 20.

    PMID: 22265143DERIVED

MeSH Terms

Conditions

KeratoconusCorneal Diseases

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Adimara C Renesto, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Mauro S Campos, MD

    Federal University of São Paulo

    STUDY CHAIR

  • Marta F Sartori, MD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

October 1, 2010

Last Updated

January 7, 2011

Record last verified: 2011-01

Locations

BR(1)