Unstable CorneasPhase 3NCT02095730
Corneal Cross-Linking Comparing Variables
A Phase 3 study testing Epithelium-On Riboflavin, Epithelium-Off Riboflavin and UV Light - Continuous Beam in people with Unstable Corneas, run by Crowd Health Research, LTD at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Unstable Corneas
- What is being tested?
- Epithelium-On Riboflavin, Epithelium-Off Riboflavin and UV Light - Continuous Beam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2014to May 2016
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- Having a clinical diagnosis of progressive keratoconus consistent with:
- An increase of ≥ 1.00 D in the steepest keratometry value
- An increase of ≥ 1.00 D in astigmatism manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Presence of central or inferior steepening on the topography map.
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- Axial topography consistent with keratoconus
- Steepest keratometry (Kmax) value ≥ 47.00 D
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact lens removal prior to evaluation and treatment
- History of having undergone a keratorefractive procedure and:
- Steepening by topography
- Thinning of cornea
- Shift in the position of thinnest portion of cornea
- Change in refraction with increasing myopia
- Development of myopic astigmatism
- Development of irregular astigmatism
- Loss of Best Spectacle Corrected Visual Acuity
- At least two of the above criteria must be present.
- Should the patient have undergone prior Intacs or other intra-corneal ring segment surgery for keratoconus or post-surgical ectasia at least 6 months prior, and is also experiencing at least two of the above ectasia symptoms, they can be included in the study.
- These patients would have the choice of ring explant before Cross-Linking.
- Cross-Linking may still be performed if the patient wishes to retain the rings.
- Should a patient's situation due to factors such as significantly high myopia or astigmatism should warrant simultaneous placement of Intacs and cross-linking in the investigators opinion, then this option can be offered to the patient. Such interventions would be tracked as a different arm of the study.
- History of having undergone radial keratotomy (RK) and or astigmatic keratotomy (AK) surgery.
- Expressing complaints about difficulties due to vision changing during the same day.
- A difference in their Manifest Refraction (MRx) of greater than 0.75 D measured on the same day, at least 6 hours apart.
- Intacs surgery will not be considered in patients with RK/AK.
Who cannot join
- Eyes classified as either normal, atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
- A history of chemical injury or delayed epithelial healing in the eye to be treated.
- A known sensitivity to study medications
- Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
- Inability to cooperate with diagnostic tests.
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- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- Patients who are unable to remain comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Eye Consultants of Atlanta
Atlanta, Georgia, 30339
Teresa Long, 404-351-2220, teresa_long@eyeconsultants.net
W. Barry Lee, MD
Icon Lasik
Denver, Colorado, 80210
Richard Anderson, OD, 720-524-1001, ra@icondenver.com
Douglas Campbell, DO
Midwest Center for Sight
Des Plaines, Illinois, 60016
James Katz, MD, 847-824-3127, jamesakatz@aol.com
James Katz, MD
James Lewis MD PC
Elkins Park, Pennsylvania, 19027
James Lewis, MD, 215-886-9090, jslewis@jameslewis.com
James Lewis, MD
Loden Vision Centers
Goodlettsville, Tennessee, 37072
Katie Lambeth, 615-859-3937, klamberth@lodenvision.com
James Loden, MD
Memorial Eye Institute
Harrisburg, Pennsylvania, 17112
Sherrie Reed, 717-657-2020, crosslinkstudy@memorialeye.com
Bennett Chotiner, MD
Southern Eye Center
Hattiesburg, Mississippi, 39402
Cameron Griffith, MD, 318-464-0306, csgriff1@earthlink.net
Cameron Griffith, MD
Gulani Vision Institute
Jacksonville, Florida, 32216
Arun Gulani, MD, 904-296-7393, gulanivision@gulani.com
Arun Gulani, MD
LASIK of Nevada
Las Vegas, Nevada, 89123
Valerie Serett, 702-636-2010, vserette@yahoo.com
Richard Rothman, MD
Discover Vision Center
Leawood, Kansas, 66211
Misty Robe, Associate's, 816-478-1230, mrobe@discovervision.com
John Doane, MD
Carolina Eye Care
Mt. Pleasant, South Carolina, 29464
Helga Sandoval, MD, 843-881-3937, helga.sandoval@carolinaeyecare.com
Kerry Solomon, MD
Bond Eye Associates
Pekin, Illinois, 61554
William Bond, MD, 309-353-6660, pekineye@yahoo.com
William Bond, MD
Parkhurst NuVision
San Antonio, Texas, 78229
Amy Ford, 210-428-6788, nuvision.amy@gmail.com
Gregory D Parkhurst, MD
LaserVue Eye
Santa Rosa, California, 95403
Jay Bansal, MD, 707-522-6200, bansal@laservue.com
Jay Bansal, MD
Mercy Clinic Eye Specialists
Springfield, Missouri, 65807
Stephanie Sekscinski, 417-820-9393, stephanie.sekscinski@mercy.net
Shachar Tauber, MD
Liberty Laser Eye Center
Vienna, Virginia, 22182
Travis A Johnson, Bachelor's, 571-234-5678 ext. 104, tjohnson@libertylasereye.com
Nancy A Tanchel, MD
About this study
Official title: Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
- Conditions
- Unstable Corneas
- Being tested
- Epithelium-On Riboflavin, Epithelium-Off Riboflavin, UV Light - Continuous Beam, UV Pulsed Beam
- Keywords
- crosslinking, cornea, keratoconus, ectasia, irradiance, riboflavin
- Medical subject headings
- Corneal Diseases, Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epithelium-On RiboflavinDrug
Also called Vitamin B2
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Epithelium-Off RiboflavinDrug
Also called Vitamin B2
Riboflavin 0.1% Phosphate Sodium solution
UV Light - Continuous BeamDevice
Also called Peschke Vario CCL-365 UV system
5 minutes of constant UV exposure to saturated cornea
UV Pulsed BeamDevice
Also called Peschke Vario CCL-365 UV system
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Epi-On Continuous | Active comparator | Continuous beam of UV light treating cornea with surface epithelium present Receives: Drug: Epithelium-On Riboflavin; Device: UV Light - Continuous Beam |
| Epi-Off Continuous | Active comparator | Continuous beam of UV light treating cornea without surface epithelium present Receives: Drug: Epithelium-Off Riboflavin; Device: UV Light - Continuous Beam |
| Epi-On Pulsed | Active comparator | Pulsed beam of UV light treating cornea with surface epithelium present Receives: Drug: Epithelium-On Riboflavin; Device: UV Pulsed Beam |
| Epi-Off Pulsed | Active comparator | Pulsed beam of UV light treating cornea without surface epithelium present Receives: Drug: Epithelium-Off Riboflavin; Device: UV Pulsed Beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Uncorrected visual acuity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable CorneasStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crowd Health Research, LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy A Tanchel, MD, Principal investigator, Liberty Laser Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095730
- Sponsor's protocol ID
- CXL-CHR 1
- Status last verified
- Mar 2014
- First submitted
- 20 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery
- ClinicalTrials.gov ID
- NCT02095730
- Acronym / sponsor ID
- CXL-CHR 1
- Conditions
- Unstable Corneas
- Keywords
- crosslinking, cornea, keratoconus, ectasia, irradiance, riboflavin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Crowd Health Research, LTDUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- First posted
- 26 Mar 2014 (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 Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epi-On Continuous | Active comparator | Drug: Epithelium-On Riboflavin, Device: UV Light - Continuous BeamContinuous beam of UV light treating cornea with surface epithelium present |
| Epi-Off Continuous | Active comparator | Drug: Epithelium-Off Riboflavin, Device: UV Light - Continuous BeamContinuous beam of UV light treating cornea without surface epithelium present |
| Epi-On Pulsed | Active comparator | Drug: Epithelium-On Riboflavin, Device: UV Pulsed BeamPulsed beam of UV light treating cornea with surface epithelium present |
| Epi-Off Pulsed | Active comparator | Drug: Epithelium-Off Riboflavin, Device: UV Pulsed BeamPulsed beam of UV light treating cornea without surface epithelium present |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- 12 years of age or older
- Having a clinical diagnosis of progressive keratoconus consistent with:
- Presence of central or inferior steepening on the topography map.
- Axial topography consistent with keratoconus
- Steepest keratometry (Kmax) value ≥ 47.00 D
Key exclusion criteria (9 listed)
- Eyes classified as either normal, atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
- A history of chemical injury or delayed epithelial healing in the eye to be treated.
- A known sensitivity to study medications
- Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
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 |
|---|---|---|
| Epithelium-On RiboflavinAlso: Vitamin B2Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative | Drug | Epi-On Continuous, Epi-On Pulsed |
| Epithelium-Off RiboflavinAlso: Vitamin B2Riboflavin 0.1% Phosphate Sodium solution | Drug | Epi-Off Continuous, Epi-Off Pulsed |
| UV Light - Continuous BeamAlso: Peschke Vario CCL-365 UV system5 minutes of constant UV exposure to saturated cornea | Device | Epi-Off Continuous, Epi-On Continuous |
| UV Pulsed BeamAlso: Peschke Vario CCL-365 UV system5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes | Device | Epi-Off Pulsed, Epi-On Pulsed |
Primary outcome
Visual Acuity
Time frame: 2 years
Uncorrected visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Nancy A Tanchel, MD principal investigator
Liberty Laser Eye Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epithelium-On Riboflavin, Epithelium-Off Riboflavin and UV Light - Continuous Beam in people with Unstable Corneas, run by Crowd Health Research, LTD at 16 sites 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 28 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 Travis A Johnson, Bachelor's (571-234-5678 ext. 104, tjohnson@libertylasereye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 2 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 26 Mar 2014.