KeratoconusPhase 2NCT01325298
UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia
A Phase 2 study testing UV-X Light and Riboflavin in people with Keratoconus and Ectasia, run by Mercy Center for Corrective Eye Surgery at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia. Read more about this study
- Who is it for?
- Ages 14 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Ectasia, Corneal Ectasia
- What is being tested?
- UV-X Light and Riboflavin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2014
- Phase
- Phase 2
- 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 14 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14 years or older for keratoconus subjects since disease often begins at puberty, and 18 years or older for post-refractive surgery keratectasia and post-transplant patients
- Signed, dated, written informed consent
- Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 24 months or less before randomization:
- An increase of at least 1.0 diopter in the steepest keratometry value (or sim K), or
- an increase of at least 1.0 diopter in regular astigmatism evaluated by subjective manifest refraction, or
- a myopic shift (decrease in the spherical equivalent) of at least 0.5 diopters on subjective refraction, or
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- documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia
- Have minimal preoperative corneal thickness of 375 microns or more, as measured in the office with epithelium not yet removed
- For subjects with non-post refractive surgery keratoconus diagnosis only:
- 14 years or older to 55 years of age,
- axial topography consistent with keratoconus such as presence of abnormal central or paracentral steepening on the corneal topography map, or presence of one or more slit lamp findings associated with keratoconus, such as
- Fleischer ring
- Vogt striae
- Corneal thinning
- Corneal scarring
- For contact lens wearers only:
- Removal of contact lenses for the required period of time prior to final screening refraction:
- Contact lens minimum discontinuation time two weeks for soft, extended wear, soft toric, and rigid gas permeable lenses
- For patients with post-refractive surgery keratectasia:
- History of excimer laser refractive surgery with increasing refractive astigmatism and corneal topographic or keratometric astigmatism of 0.5 or more, or a history of decreasing best spectacle corrected visual acuity associated with the presence of topography suggestive of keratoconus or pellucid marginal degeneration or abnormal higher order aberrations (especially coma) on the aberration mapping of the eye.
- For patients with corneal transplants:
- History of corneal transplant for keratoconus with documented increasing refractive astigmatism and corresponding topographic irregularity occurring at least one year after corneal transplantation, not attributable to transplant suture removal and occurring during the most recent two years.
Who cannot join
- Patients with excessively thin corneas. (Intraoperative minimal corneal thickness in the swollen state with the epithelium removed must exceed 400 microns)
- Keratometric readings greater than 62D
- No evidence of keratoconus/keratectasia progression over the prior three years
- Age less than 55 years but under
- 14 years for keratoconus patients
- 18 years for post-refractive surgery keratectasia and post-transplant patients
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- Previous ocular condition in the eye(s) to be treated that might, in the investigator's opinion, predispose to complications (such as history herpes simplex keratitis, corneal melt, perforated corneal ulcer, descemetocele, prior corneal damage from chemical injury, herpes zoster keratitis, nystagmus, corneal scarring that significantly impairs vision, pre-existing glaucoma, glaucoma suspect, Goldmann applanation pressure exceeding 23 mm Hg, cataract, history of uveitis, active ocular disease that might lead to infection, corneal endothelial cell count below 1800 cells per square millimeter)
- Patients with a systemic condition that, in the investigator's opinion, might predispose to complications (such as Down syndrome, autoimmune disease, pregnancy or nursing at the time of initial treatment, history of alcohol abuse, being immunocompromised, allergy to riboflavin or other study medications)
- Patients who are unwilling or unable to comply with the study regimen and doctor's advice
- Patients unwilling to discontinue wear of rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post-operatively
- Patient unwilling to discontinue contact lenses prior to baseline exam: one week for soft lenses, two weeks for rigid or soft toric lenses
- Pregnancy at the time of proposed crosslinking
- Known hypersensitivity to riboflavin
- Central corneal endothelial cell count below 1400 cells per square millimeter.
- Presence of significant central corneal stromal scar
- History of delayed wound healing
- Immunocompromised patient
- History of connective tissue disease (such as systemic lupus erythematosus, rheumatoid arthritis)
- History of glaucoma, a Goldmann applanation pressure measured in keratoconus evaluation of above 24, or glaucoma suspect, xviii. Significant existing cataract
- Macular degeneration or confluent drusen of Bruchs membrane
- Evidence of past or present herpes simplex of the cornea
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mercy Center for Corrective Eye Surgery
McHenry, Illinois, 60050
Mark Gurgos, COT, 815-363-2020, mgurgos@mhsjvl.org
Robert L Epstein, MD, 815-363-2020, rlepstein@aol.com
About this study
The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.
- Conditions
- Keratoconus, Ectasia, Corneal Ectasia
- Being tested
- UV-X Light, Riboflavin
- Keywords
- Keratoconus, Ectasia, cross linking, collagen cross linking, corneal crosslinking, corneal diseases, eye diseases
- Medical subject headings
- Keratoconus, Dilatation, Pathologic, Corneal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV-X LightDevice
UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
RiboflavinDrug
Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
UV-X LightDevice
UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
RiboflavinDrug
Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
| Study group | Role | What they receive |
|---|---|---|
| 20 Minute UV-X Light Treatment Duration | Active comparator | 20 Minute UV-X Light Treatment Duration
Note: "UV-X" is the trademark of Peschke GmbH Receives: Device: UV-X Light; Drug: Riboflavin |
| 30 Minute UV-X Light Treatment Duration | Active comparator | 30 Minute UV-X Light Treatment Duration Receives: Device: UV-X Light; Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal curvature
Measured by maximum keratometry (Kmax)
Measured: 6 months
Secondary outcomes (3)
corrected distance acuity
best spectacle corrected distance acuity
Measured: 6 months
corneal endothelial cell count
Measured: 6 months
pachymetry
Minimal corneal thickness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Center for Corrective Eye Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Robert L Epstein, MD, Principal investigator, Mercy Center for Corrective Eye Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325298
- Sponsor's protocol ID
- IND 109752
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
PubMed 20138607Goldich Y, Marcovich AL, Barkana Y, Avni I, Zadok D. Safety of corneal collagen cross-linking with UV-A and riboflavin in progressive keratoconus. Cornea. 2010 Apr;29(4):409-11. doi: 10.1097/ICO.0b013e3181bd9f8c.
PubMed 20164744Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
PubMed 18811118Raiskup-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 18471635Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. doi: 10.1177/112067210601600405.
PubMed 16952090Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
PubMed 16765803
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia
- ClinicalTrials.gov ID
- NCT01325298
- Acronym / sponsor ID
- IND 109752
- Conditions
- Keratoconus, Ectasia, Corneal Ectasia
- Keywords
- Keratoconus, Ectasia, cross linking, collagen cross linking, corneal crosslinking, corneal diseases, eye diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mercy Center for Corrective Eye SurgeryUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 29 Mar 2011 (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 primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 Minute UV-X Light Treatment Duration | Active comparator | Device: UV-X Light, Drug: Riboflavin20 Minute UV-X Light Treatment Duration Note: "UV-X" is the trademark of Peschke GmbH |
| 30 Minute UV-X Light Treatment Duration | Active comparator | Device: UV-X Light, Drug: Riboflavin30 Minute UV-X Light Treatment Duration |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Age 14 years or older for keratoconus subjects since disease often begins at puberty, and 18 years or older for post-refractive surgery keratectasia and post-transplant patients
- Signed, dated, written informed consent
- Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 24 months or less before randomization:
- An increase of at least 1.0 diopter in the steepest keratometry value (or sim K), or
- an increase of at least 1.0 diopter in regular astigmatism evaluated by subjective manifest refraction, or
Key exclusion criteria (21 listed)
- Patients with excessively thin corneas. (Intraoperative minimal corneal thickness in the swollen state with the epithelium removed must exceed 400 microns)
- Keratometric readings greater than 62D
- No evidence of keratoconus/keratectasia progression over the prior three years
- Age less than 55 years but under
- 14 years for keratoconus patients
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 |
|---|---|---|
| UV-X LightUV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1% | Device | 20 Minute UV-X Light Treatment Duration |
| RiboflavinRiboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment. | Drug | 20 Minute UV-X Light Treatment Duration |
| UV-X LightUV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1% | Device | 30 Minute UV-X Light Treatment Duration |
| RiboflavinRiboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment. | Drug | 30 Minute UV-X Light Treatment Duration |
Primary outcome
Change in corneal curvature
Time frame: 6 months
Measured by maximum keratometry (Kmax)
3 secondary outcomes
corrected distance acuity
Time frame: 6 months
corneal endothelial cell count
Time frame: 6 months
pachymetry
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Results publication: PubMed 20138607Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
- Results publication: PubMed 20164744Goldich Y, Marcovich AL, Barkana Y, Avni I, Zadok D. Safety of corneal collagen cross-linking with UV-A and riboflavin in progressive keratoconus. Cornea. 2010 Apr;29(4):409-11. doi: 10.1097/ICO.0b013e3181bd9f8c.
- Results publication: PubMed 18811118Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
- 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.
- Results publication: PubMed 16952090Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. doi: 10.1177/112067210601600405.
- Results publication: PubMed 16765803Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
- Educational material in website of Mercy Center for Corrective Eye SurgeryLink provided by the sponsor.
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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.
Robert L Epstein, MD principal investigator
Mercy Center for Corrective Eye Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UV-X Light and Riboflavin in people with Keratoconus and Ectasia, run by Mercy Center for Corrective Eye Surgery 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 22 inclusion and 21 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 Mar 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Charisse Haas (815-363-2020, chaas@mhsjvl.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal curvature (time frame: 6 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 NCT01325298, which also lists 6 linked publications.
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 Mar 2011.