Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
April 22, 2008 updated by: Universidade Federal do Rio de Janeiro
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 21941-913
- Recruiting
- Clementino Fraga Filho University Hospital
-
Contact:
- Ricardo Lamy
- Email: lamy@ufrj.br
-
Principal Investigator:
- Ricardo Lamy, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
The eye with the worst visual acuity receives the treatment.
(the other eye serve as control).
|
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
|
|
No Intervention: B
The eye with the best visual acuity do not receive the treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Keratometry
Time Frame: 3 months
|
3 months
|
|
BSCVA (Best spectacle corrected visual acuity)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endothelial cell count
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ricardo Lamy, MD, UFRJ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Anticipated)
December 1, 2008
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
April 23, 2008
Last Update Submitted That Met QC Criteria
April 22, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005/07-CEP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.