KeratoconusPhase 2/3NCT00435799
Evaluating Collagen Cross-Linking (CCL) Treatment in Norway
A Phase 2/3 study testing corneal cross-linking (CCL), Riboflavin/dextran eyedrops and UV-X system in people with Keratoconus, run by Ullevaal University Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- corneal cross-linking (CCL), Riboflavin/dextran eyedrops and UV-X system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2007to Jan 2010
- Phase
- Phase 2/3
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 45 years
- Progressive keratectasia (primary or secondary) in an advanced stage
- Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses
- Rigid contact lenses are either not tolerated or do not improve visual acuity
- No previous eye surgery (except for laser refractive surgery)
- All patients must provide written informed consent to become a study subject
- Subjects able to return for scheduled follow-up examinations according to this protocol
Who cannot join
- Corneal thickness < 400 µm at thinnest position
- Keratometric - readings above 60 diopters
- Other active ocular disease than keratectasia
- Herpes keratitis
- Previous ocular surgery (other than laser refractive surgery)
- Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease
Show all 9Show fewer
- Patients with known sensitivity to study medication
- Subjects with intraocular pressure > 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects
- Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Eye dpt, Ullevål University Hospital
Oslo, Oslo, N-0407
Liv Drolsum, Prof MD PhD, +47 22118545, liv.drolsum@uus.no
Espen F Bakke, MD, +47 22118545, espen.bakke@medisin.uio.no
- Recruiting
Eye dpt, University Hospital North Norway
Tromsø, Tromsø, No-9037
Aleksandar Stojanovic, MD, +47 77 64 79 20, aleks@online.no
Aleksandar Stojanovic, MD
About this study
Official title: Treatment of Keratectasia With Collagen Cross-Linking (CCL) at the Eye Departments of the University Hospital, North Norway in Tromsø and Ullevål University Hospital in Oslo
The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.
Read the detailed description
The technique of corneal collagen cross-linking consists of photopolymerization of stromal fibers by combined action of a photosensitizing substance, riboflavin and ultraviolet type A rays (UVA) from a solid-state UVA Source. Photopolymerization increases the rigidity of corneal collagen and its resistance to keratectasia. It has been used to stop progression of keratectasia.
Corneal transplantation has been the only available option so far for treatment for keratectasia in its advanced stage in Norway. The method of CCL using riboflavin and UV light is technically simple and much less invasive than corneal transplantation and it treats and prevents the underlying pathophysiological mechanism. It also does not reduce the chances for a successful corneal transplantation, in case that would still be necessary after CCL.
The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.
- Conditions
- Keratoconus
- Being tested
- corneal cross-linking (CCL), Riboflavin/dextran eyedrops, UV-X system
- Keywords
- keratoconus, corneal cross-linking, riboflavine, ultraviolet type A rays (UVA)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal cross-linking (CCL)Procedure or surgery
Also called Riboflavine, UVX
Riboflavin/dextran eyedropsDrug
UV-X systemDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Procedure: corneal cross-linking (CCL); Drug: Riboflavin/dextran eyedrops; Device: UV-X system |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.
2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Aleksandar Stojanovic, MD, Principal investigator, Eye dpt, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435799
- Sponsor's protocol ID
- UNN-UUS-CCL07
- Status last verified
- Jan 2007
- First submitted
- 13 Feb 2007
- Last updated
- 10 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Keratectasia With Collagen Cross-Linking (CCL) at the Eye Departments of the University Hospital, North Norway in Tromsø and Ullevål University Hospital in Oslo
- ClinicalTrials.gov ID
- NCT00435799
- Acronym / sponsor ID
- UNN-UUS-CCL07
- Conditions
- Keratoconus
- Keywords
- keratoconus, corneal cross-linking, riboflavine, ultraviolet type A rays (UVA)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 15 Feb 2007 (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 assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.
Detailed description
The technique of corneal collagen cross-linking consists of photopolymerization of stromal fibers by combined action of a photosensitizing substance, riboflavin and ultraviolet type A rays (UVA) from a solid-state UVA Source. Photopolymerization increases the rigidity of corneal collagen and its resistance to keratectasia. It has been used to stop progression of keratectasia.
Corneal transplantation has been the only available option so far for treatment for keratectasia in its advanced stage in Norway. The method of CCL using riboflavin and UV light is technically simple and much less invasive than corneal transplantation and it treats and prevents the underlying pathophysiological mechanism. It also does not reduce the chances for a successful corneal transplantation, in case that would still be necessary after CCL.
The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: corneal cross-linking (CCL), Drug: Riboflavin/dextran eyedrops, Device: UV-X system |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 20 to 45 years
- Progressive keratectasia (primary or secondary) in an advanced stage
- Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses
- Rigid contact lenses are either not tolerated or do not improve visual acuity
- No previous eye surgery (except for laser refractive surgery)
Key exclusion criteria (9 listed)
- Corneal thickness < 400 µm at thinnest position
- Keratometric - readings above 60 diopters
- Other active ocular disease than keratectasia
- Herpes keratitis
- Previous ocular surgery (other than laser refractive surgery)
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 cross-linking (CCL)Also: Riboflavine, UVX | Procedure or surgery | A |
| Riboflavin/dextran eyedrops | Drug | A |
| UV-X system | Device | A |
Primary outcome
1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.
2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
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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.
Aleksandar Stojanovic, MD principal investigator
Eye dpt, University Hospital of North Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing corneal cross-linking (CCL), Riboflavin/dextran eyedrops and UV-X system in people with Keratoconus, run by Ullevaal University Hospital at 2 sites in Norway.
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 7 inclusion and 9 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 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ALEKSANDAR STOJANOVIC, MD (+47 77 64 79 20, aleks@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2008; AzTrials last refreshed its copy on 6 Nov 2026.