Corneal Ectasia Disorders Including KeratoconusPhase 3NCT01708538
The Effects of Corneal Collagen Cross-linking
A Phase 3 study testing CXL in people with Corneal Ectasia Disorders Including Keratoconus, run by Rush Eye Associates at 1 site in United States.
Trial summary
The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Corneal Ectasia Disorders Including Keratoconus
- What is being tested?
- CXL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2024
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10-70, willing to participate, diagnosis of corneal ectasia disorder
Who cannot join
- Unwilling or unable to participate in trial
Trial locations and contacts
1 site in 1 country.
Sloan W Rush, MD contact
United States1 site, 1 recruiting
- Recruiting
Rush Eye Associates
Amarillo, Texas, 79106
Sunday Fowler, 806-353-0125
Sloan W Rush, MD
About this study
Official title: Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.
The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.
- Being tested
- CXL
- Keywords
- keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXLDrug
corneal crosslinking
| Study group | Role | What they receive |
|---|---|---|
| Epithelium on | Active comparator | Epi not removed during CXL treatment Receives: Drug: CXL |
| Epithelium off | Active comparator | Epi removed before CXL treatment Receives: Drug: CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Best corrected Snellen acuity
Measured: 1 year
Keratometry measurements
Average curvature of the cornea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (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 Corneal Ectasia Disorders Including 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush Eye Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708538
- Sponsor's protocol ID
- Rush CXL
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2012
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rush SW, Rush RB. Epithelium-off versus transepithelial corneal collagen crosslinking for progressive corneal ectasia: a randomised and controlled trial. Br J Ophthalmol. 2017 Apr;101(4):503-508. doi: 10.1136/bjophthalmol-2016-308914. Epub 2016 Jul 7.
PubMed 27388250
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.
- ClinicalTrials.gov ID
- NCT01708538
- Acronym / sponsor ID
- Rush CXL
- Keywords
- keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rush Eye AssociatesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Oct 2012 (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 corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epithelium on | Active comparator | Drug: CXLEpi not removed during CXL treatment |
| Epithelium off | Active comparator | Drug: CXLEpi removed before CXL treatment |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age 10-70, willing to participate, diagnosis of corneal ectasia disorder
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in trial
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 |
|---|---|---|
| CXLcorneal crosslinking | Drug | Epithelium off, Epithelium on |
Primary outcome
Visual acuity
Time frame: 1 year
Best corrected Snellen acuity
Keratometry measurements
Time frame: 1 year
Average curvature of the cornea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 27388250Rush SW, Rush RB. Epithelium-off versus transepithelial corneal collagen crosslinking for progressive corneal ectasia: a randomised and controlled trial. Br J Ophthalmol. 2017 Apr;101(4):503-508. doi: 10.1136/bjophthalmol-2016-308914. Epub 2016 Jul 7.
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.
Sloan W Rush, MD contact
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 CXL in people with Corneal Ectasia Disorders Including Keratoconus, run by Rush Eye Associates 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 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 26 Oct 2022. 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 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 Sloan W Rush, MD (806-353-0125), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 year). 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 NCT01708538, 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 26 Oct 2022.