KeratoconusPhase 2/3NCT01081561
Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
A Phase 2/3 study testing Riboflavin in people with Keratoconus and Ectasia, run by Yaron S. Rabinowitz M.D. at 1 site in United States.
Trial summary
This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Keratoconus, Ectasia
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2009to 30 Jun 2021
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- progressive keratoconus or ectasia
Who cannot join
- cornea thinner than 400um
- K readings greater than 60D
- Central corneal scarring
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea Eye Institute, 50 North La Cienaga Blvd, #340
Beverly Hills, California, 90211
About this study
Official title: Randomized Study of Corneal Collagen Cross-Linking With the UV-X System for the Treatment of Keratectasia in Eyes With Intacs Compared to Eyes Without Intacs
This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.
Read the detailed description
In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.
These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact
- Conditions
- Keratoconus, Ectasia
- Being tested
- Riboflavin
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Also called Peschke Meditrade
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
| Study group | Role | What they receive |
|---|---|---|
| Cross-linking | Active comparator | Corneal collagen cross-linking with riboflavin and UVA light Receives: Drug: Riboflavin |
| Cross-linking plus INTACS | Active comparator | Corneal collagen cross-linking with riboflavin and UVA light plus INTACS Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of UV-X cross linking to halt progression of keratoconus
Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start21 Jan 2009
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaron S. Rabinowitz M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
- Investigators
- Yaron S Rabinowitz, M.D., Principal investigator, Cornea Genetic Eye InstituteEzra Maguen, M.D., Principal investigator, american eye instituteYuri Oleynikov, M.D. PhD, Principal investigator, Cornea Genetic Eye InstituteJames Salz, M.D., Principal investigator, Laser Eye AssociatesRonald Gaster, MD, Principal investigator, Cornea Eye Institute, Beverly Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081561
- Sponsor's protocol ID
- #20090780
- Status last verified
- Dec 2017
- First submitted
- 4 Mar 2010
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Corneal Collagen Cross-Linking With the UV-X System for the Treatment of Keratectasia in Eyes With Intacs Compared to Eyes Without Intacs
- ClinicalTrials.gov ID
- NCT01081561
- Acronym / sponsor ID
- #20090780
- Conditions
- Keratoconus, Ectasia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yaron S. Rabinowitz M.D.University, hospital or other
- Study start
- 21 Jan 2009 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 5 Mar 2010 (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.
This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.
Detailed description
In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.
These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-linking | Active comparator | Drug: RiboflavinCorneal collagen cross-linking with riboflavin and UVA light |
| Cross-linking plus INTACS | Active comparator | Drug: RiboflavinCorneal collagen cross-linking with riboflavin and UVA light plus INTACS |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- progressive keratoconus or ectasia
Key exclusion criteria (3 listed)
- cornea thinner than 400um
- K readings greater than 60D
- Central corneal scarring
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 |
|---|---|---|
| RiboflavinAlso: Peschke MeditradeRemoval of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin. | Drug | Cross-linking, Cross-linking plus INTACS |
Primary outcome
Effectiveness of UV-X cross linking to halt progression of keratoconus
Time frame: 10 years
Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Yaron S Rabinowitz, M.D. principal investigator
Cornea Genetic Eye Institute
Ezra Maguen, M.D. principal investigator
american eye institute
Yuri Oleynikov, M.D. PhD principal investigator
Cornea Genetic Eye Institute
1 site 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 Riboflavin in people with Keratoconus and Ectasia, run by Yaron S. Rabinowitz M.D. at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. 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 United States. 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?
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?
Effectiveness of UV-X cross linking to halt progression of keratoconus (time frame: 10 years). 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 2 Oct 2018.