KeratoconusNCT00642044
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
A study testing Corneal Collagen Crosslinking in people with Keratoconus, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal Collagen Crosslinking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 35 years.
- Diagnosis of Keratoconus.
- Progression of Ametropia.
- Written informed consent.
Who cannot join
- Corneal Thickness < 395 micra at thinnest point.
- Other active ocular disease than keratectasia.
- Cornea Guttata.
- Previous ocular surgery.
- Pregnancy.
- Known sensitivity to riboflavin.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clementino Fraga Filho University Hospital
Rio de Janeiro, Rio de Janeiro, 21941-913
Ricardo Lamy, lamy@ufrj.br
Ricardo Lamy, MD
About this study
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.
- Conditions
- Keratoconus
- Being tested
- Corneal Collagen Crosslinking
- Keywords
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Collagen CrosslinkingProcedure or surgery
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | The eye with the worst visual acuity receives the treatment. (the other eye serve as control). Receives: Procedure: Corneal Collagen Crosslinking |
| B | No intervention | The eye with the best visual acuity do not receive the treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratometry
Measured: 3 months
BSCVA (Best spectacle corrected visual acuity)
Measured: 3 months
Secondary outcomes (1)
Endothelial cell count
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startFeb 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo Lamy, MD, Principal investigator, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642044
- Sponsor's protocol ID
- 005/07-CEP
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12719068Spoerl 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.
PubMed 9533835Kolozsvari 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.
PubMed 12091412Sekundo 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.
PubMed 11201780Caporossi 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.
PubMed 16765803Spoerl 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.
PubMed 17457183Wollensak 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.
PubMed 14522301
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
- ClinicalTrials.gov ID
- NCT00642044
- Acronym / sponsor ID
- 005/07-CEP
- Conditions
- Keratoconus
- Keywords
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Corneal Collagen CrosslinkingThe eye with the worst visual acuity receives the treatment. (the other eye serve as control). |
| B | No intervention | –The eye with the best visual acuity do not receive the treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 35 years.
- Diagnosis of Keratoconus.
- Progression of Ametropia.
- Written informed consent.
Key exclusion criteria (6 listed)
- Corneal Thickness < 395 micra at thinnest point.
- Other active ocular disease than keratectasia.
- Cornea Guttata.
- Previous ocular surgery.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Collagen CrosslinkingUV light and Riboflavin eyedrops every 5 minutes for 30 minutes. | Procedure or surgery | A |
Primary outcome
Keratometry
Time frame: 3 months
BSCVA (Best spectacle corrected visual acuity)
Time frame: 3 months
1 secondary outcome
Endothelial cell count
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Background: PubMed 12719068Wollensak 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.
- Background: PubMed 9533835Spoerl 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.
- Background: PubMed 12091412Kolozsvari 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.
- Background: PubMed 11201780Sekundo 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.
- Background: PubMed 16765803Caporossi 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.
- Background: PubMed 17457183Spoerl 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.
- Background: PubMed 14522301Wollensak 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.
- Clementino Fraga Filho University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Lamy, MD principal investigator
UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Collagen Crosslinking in people with Keratoconus, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Lamy, MD (55-21-2714-7646, lamy@ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratometry (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642044, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2008.