Cornea DegenerationPhase 3NCT00815256
Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus
A Phase 3 study testing Collagen Cross Linking with Riboflavin and UVA light in people with Cornea Degeneration and Progressive Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Cornea Degeneration, Progressive Keratoconus
- What is being tested?
- Collagen Cross Linking with Riboflavin and UVA light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Aug 2009
- Phase
- Phase 3
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Keratoconus patients, with progression of the disease, based on an increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on pentacan, in a period of at least six months.
Who cannot join
- pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Federal University of São Paulo
São Paulo, São Paulo
Patricia Z Serapicos, MD, patricia.serapicos@yahoo.com.br
Kátia M Bottós, MD, katia.bottos@gmail.com
About this study
Official title: The Safety and Effectiveness of Collagen Cross Linking With Riboflavin and Ultraviolet-A Light in Progressive Mild and Moderate Grades of Keratoconus.
The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.
Read the detailed description
Keratoconus is a corneal degeneration characterized by bilateral conical protusion and corneal thinning. The course of the disease varies from slight irregular astigmatism to severe visual impairment due to increasing protrusion and subepithelial scarring. There is no treatment available that can stop keratoconus progression. Thus, because of its progressive nature, keratoconus is the most frequent reason for keratoplasty worldwide in the past 3 decades.
The collagen crosslinking (CXL) technique using riboflavin and ultraviolet - A (UVA) light was recently developed to counteract the progressive corneal thinning, and thus the progression of keratoconus. With crosslinking, additional covalent binding between collagen molecules can be achieved, which stabilizes the collagen scaffold and enhances corneal resistance.
Prospective longitudinal randomized case-control study including progressive keratoconus cases is addressed to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus. Progression is based on increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on Pentacan, in a period of at least six months. All patients must be between 15 and 40 year old and are randomized and allocated in the treated or the control groups. Complete exam before and after exam included best corrected visual acuity, refraction, IOP, fundoscopy, imaging exams such as corneal computerized topographic, pentacan, orbscan, ultrasound pachymetry, esthesiometry, endothelial cell count, HRT II system confocal microscopy, optic coherence tomography (VISANTE), ORA , optic coherence tomography (Stratus OCT) and dynamic contour tonometry . All the exams are repeated 1, 3, 6 and 12 months after the procedure. The cross linking is performed as follows: after topical anesthesia, the epithelial tissue is removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution is applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution is continuously applied onto the cornea every 5 min.
- Conditions
- Cornea Degeneration, Progressive Keratoconus
- Being tested
- Collagen Cross Linking with Riboflavin and UVA light
- Keywords
- Cornea degeneration, keratoconus, collagen cross linking, CXL, Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Cross Linking with Riboflavin and UVA lightProcedure or surgery
The patients randomized and allocated to this group are submitted to the treatment with riboflavin and ultraviolet -A light, if they do not match any of the exclusion criterion. The treatment is done as follows:after topical anesthesia, the epithelial tissue was removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution were applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution were continuously applied onto the cornea every 5 min. After the procedure, a therapeutic contact lens and antibiotic eye ointment are applied onto the cornea for a week. We see the patient in the next day.
| Study group | Role | What they receive |
|---|---|---|
| Cross linking (CXL) | Experimental | Patients with progressive mild and moderate grades of ketatoconus are randomized and allocated to this group and submitted to the treatment with riboflavin and ultraviolet -A light. They do not match any of the exclusion criterion: pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy. Receives: Procedure: Collagen Cross Linking with Riboflavin and UVA light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop progression of keratoconus in cornea imaging exams
Measured: 1, 3, 6 and 12 months
Secondary outcomes (1)
Increase in the collagen fibrils density in the confocal microscopy; sensitivity in the esthesiometry; Keratometry (stabilizes or reduces) in the topography; anterior chamber depth on pentacan; etc
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cornea DegenerationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Denise D Freitas, Professor, Study chair, Ophthalmology Department Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815256
- Sponsor's protocol ID
- 1970/07
- Status last verified
- Nov 2008
- First submitted
- 26 Dec 2008
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
PubMed 18471635
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Collagen Cross Linking With Riboflavin and Ultraviolet-A Light in Progressive Mild and Moderate Grades of Keratoconus.
- ClinicalTrials.gov ID
- NCT00815256
- Acronym / sponsor ID
- 1970/07
- Conditions
- Cornea Degeneration, Progressive Keratoconus
- Keywords
- Cornea degeneration, keratoconus, collagen cross linking, CXL, Riboflavin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- First posted
- 29 Dec 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.
The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.
Detailed description
Keratoconus is a corneal degeneration characterized by bilateral conical protusion and corneal thinning. The course of the disease varies from slight irregular astigmatism to severe visual impairment due to increasing protrusion and subepithelial scarring. There is no treatment available that can stop keratoconus progression. Thus, because of its progressive nature, keratoconus is the most frequent reason for keratoplasty worldwide in the past 3 decades.
The collagen crosslinking (CXL) technique using riboflavin and ultraviolet - A (UVA) light was recently developed to counteract the progressive corneal thinning, and thus the progression of keratoconus. With crosslinking, additional covalent binding between collagen molecules can be achieved, which stabilizes the collagen scaffold and enhances corneal resistance.
Prospective longitudinal randomized case-control study including progressive keratoconus cases is addressed to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus. Progression is based on increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on Pentacan, in a period of at least six months. All patients must be between 15 and 40 year old and are randomized and allocated in the treated or the control groups. Complete exam before and after exam included best corrected visual acuity, refraction, IOP, fundoscopy, imaging exams such as corneal computerized topographic, pentacan, orbscan, ultrasound pachymetry, esthesiometry, endothelial cell count, HRT II system confocal microscopy, optic coherence tomography (VISANTE), ORA , optic coherence tomography (Stratus OCT) and dynamic contour tonometry . All the exams are repeated 1, 3, 6 and 12 months after the procedure. The cross linking is performed as follows: after topical anesthesia, the epithelial tissue is removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution is applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution is continuously applied onto the cornea every 5 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross linking (CXL) | Experimental | Procedure: Collagen Cross Linking with Riboflavin and UVA lightPatients with progressive mild and moderate grades of ketatoconus are randomized and allocated to this group and submitted to the treatment with riboflavin and ultraviolet -A light. They do not match any of the exclusion criterion: pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Keratoconus patients, with progression of the disease, based on an increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on pentacan, in a period of at least six months.
Key exclusion criteria (1 listed)
- pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy
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 |
|---|---|---|
| Collagen Cross Linking with Riboflavin and UVA lightThe patients randomized and allocated to this group are submitted to the treatment with riboflavin and ultraviolet -A light, if they do not match any of the exclusion criterion. The treatment is done as follows:after topical anesthesia, the epithelial tissue was removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution were applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution were continuously applied onto the cornea every 5 min. After the procedure, a therapeutic contact lens and antibiotic eye ointment are applied onto the cornea for a week. We see the patient in the next day. | Procedure or surgery | Cross linking (CXL) |
Primary outcome
Stop progression of keratoconus in cornea imaging exams
Time frame: 1, 3, 6 and 12 months
1 secondary outcome
Increase in the collagen fibrils density in the confocal microscopy; sensitivity in the esthesiometry; Keratometry (stabilizes or reduces) in the topography; anterior chamber depth on pentacan; etc
Time frame: 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2008.
- Results publication: PubMed 18471635Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
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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.
Denise D Freitas, Professor study chair
Ophthalmology Department Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagen Cross Linking with Riboflavin and UVA light in people with Cornea Degeneration and Progressive 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 1 inclusion and 1 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 29 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Patricia Z Serapicos, MD (55(11)82738907, patricia.serapicos@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop progression of keratoconus in cornea imaging exams (time frame: 1, 3, 6 and 12 months). 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 NCT00815256, which also lists 1 linked publication.
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 29 Dec 2008.