KeratoconusNCT00832897
Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring
A study testing Corneal collagen crosslinking in people with Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal collagen crosslinking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Oct 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with keratoconus
- Patients that aren't using contact lenses
- Pachymetry more than 400Um
- Best visual acuity less or equal 20/30
Who cannot join
- Ocular surgeries before
- Other eye diseases
- Corneal curvature more than 65 dioptres
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- Corneal collagen crosslinking
- Keywords
- Keratoconus, riboflavin, cornea, crosslinking
- Medical subject headings
- Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal collagen crosslinkingProcedure or surgery
Also called Keratoconus., Corneal collagen crosslinking.
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.
| Study group | Role | What they receive |
|---|---|---|
| Eyedrop | Sham comparator | Not described Receives: Procedure: Corneal collagen crosslinking |
| Crosslinking | Active comparator | The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light. Receives: Procedure: Corneal collagen crosslinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive data, visual acuity, topography patterns, pachymetry measurements.
Measured: Two years
Secondary outcomes (1)
Anterior segment tomography data, corneal biomechanics, impression cytology.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Adimara C Renesto, MD, Principal investigator, Federal University of São PauloMauro S Campos, MD, Study chair, Federal University of São PauloMarta F Sartori, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832897
- Sponsor's protocol ID
- 1915/07
- Status last verified
- Jan 2011
- First submitted
- 29 Jan 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17531694Coskunseven 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.
PubMed 18291344Wollensak 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.
PubMed 15050269Renesto 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.
PubMed 22265143
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
- ClinicalTrials.gov ID
- NCT00832897
- Acronym / sponsor ID
- 1915/07
- Conditions
- Keratoconus
- Keywords
- Keratoconus, riboflavin, cornea, crosslinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jan 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyedrop | Sham comparator | Procedure: Corneal collagen crosslinking |
| Crosslinking | Active comparator | Procedure: Corneal collagen crosslinkingThe patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with keratoconus
- Patients that aren't using contact lenses
- Pachymetry more than 400Um
- Best visual acuity less or equal 20/30
Key exclusion criteria (3 listed)
- Ocular surgeries before
- Other eye diseases
- Corneal curvature more than 65 dioptres
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 crosslinkingAlso: Keratoconus., Corneal collagen crosslinking.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. | Procedure or surgery | Crosslinking, Eyedrop |
Primary outcome
Refractive data, visual acuity, topography patterns, pachymetry measurements.
Time frame: Two years
1 secondary outcome
Anterior segment tomography data, corneal biomechanics, impression cytology.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
- Background: PubMed 17531694Mencucci 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.
- Background: PubMed 18291344Coskunseven 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 publication: PubMed 15050269Wollensak 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.
- Derived from this study: PubMed 22265143Renesto 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.
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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.
Adimara C Renesto, MD principal investigator
Federal University of São Paulo
Mauro S Campos, MD study chair
Federal University of São Paulo
Marta F Sartori, MD study chair
Federal University of São Paulo
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 Federal University of São Paulo 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 3 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: finished, as of the sponsor's last update on 7 Jan 2011. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive data, visual acuity, topography patterns, pachymetry measurements. (time frame: Two years). 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 NCT00832897, which also lists 4 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 7 Jan 2011.