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Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Corneal Collagen Crosslinking
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Clementino Fraga Filho University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Keratometry
BSCVA (Best spectacle corrected visual acuity)

Secondary Outcome Measures

Endothelial cell count

Full Information

First Posted
March 17, 2008
Last Updated
April 22, 2008
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT00642044
Brief Title
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
Official Title
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
The eye with the worst visual acuity receives the treatment. (the other eye serve as control).
Arm Title
B
Arm Type
No Intervention
Arm Description
The eye with the best visual acuity do not receive the treatment.
Intervention Type
Procedure
Intervention Name(s)
Corneal Collagen Crosslinking
Intervention Description
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
Primary Outcome Measure Information:
Title
Keratometry
Time Frame
3 months
Title
BSCVA (Best spectacle corrected visual acuity)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Endothelial cell count
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 35 years. Diagnosis of Keratoconus. Progression of Ametropia. Written informed consent. Exclusion Criteria: Corneal Thickness < 395 micra at thinnest point. Other active ocular disease than keratectasia. Cornea Guttata. Previous ocular surgery. Pregnancy. Known sensitivity to riboflavin.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Lamy, MD
Phone
55-21-2714-7646
Email
lamy@ufrj.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Lamy, MD
Organizational Affiliation
UFRJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clementino Fraga Filho University Hospital
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Lamy
Email
lamy@ufrj.br
First Name & Middle Initial & Last Name & Degree
Ricardo Lamy, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12719068
Citation
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.
Results Reference
background
PubMed Identifier
9533835
Citation
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.
Results Reference
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PubMed Identifier
12091412
Citation
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.
Results Reference
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PubMed Identifier
11201780
Citation
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.
Results Reference
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PubMed Identifier
16765803
Citation
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.
Results Reference
background
PubMed Identifier
17457183
Citation
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.
Results Reference
background
PubMed Identifier
14522301
Citation
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.
Results Reference
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Links:
URL
http://www.hucff.ufrj.br
Description
Clementino Fraga Filho University Hospital

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Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

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