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Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Corneal collagen crosslinking
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, riboflavin, cornea, crosslinking

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Eyedrop

Crosslinking

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anterior segment tomography data, corneal biomechanics, impression cytology.

Full Information

First Posted
January 29, 2009
Last Updated
January 6, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00832897
Brief Title
Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring
Official Title
"Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Keratoconus is a progressive disease where cornea is thin and has a higher curvature.In early conditions, it may be corrected by glasses or contact lens.When these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree. In this study, the patients with a degree of keratoconus on I or II, will be submitted to corneal collagen crosslinking and then a corneal ring surgery. The corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-UVA irradiation, avoid the progression of the keratoconus.After three months of crosslinking, these patients will be submitted a corneal ring surgery. These patients will be allowed by two years and various exams will realized them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, riboflavin, cornea, crosslinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eyedrop
Arm Type
Sham Comparator
Arm Title
Crosslinking
Arm Type
Active Comparator
Arm Description
The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.
Intervention Type
Procedure
Intervention Name(s)
Corneal collagen crosslinking
Other Intervention Name(s)
Keratoconus., Corneal collagen crosslinking.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Refractive data, visual acuity, topography patterns, pachymetry measurements.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Anterior segment tomography data, corneal biomechanics, impression cytology.
Time Frame
Two years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with keratoconus Patients that aren't using contact lenses Pachymetry more than 400Um Best visual acuity less or equal 20/30 Exclusion Criteria: Ocular surgeries before Other eye diseases Corneal curvature more than 65 dioptres
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adimara C Renesto, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mauro S Campos, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marta F Sartori, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04038-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17531694
Citation
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.
Results Reference
background
PubMed Identifier
18291344
Citation
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.
Results Reference
background
PubMed Identifier
15050269
Citation
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.
Results Reference
result
PubMed Identifier
22265143
Citation
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.
Results Reference
derived

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Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring

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