KeratoconusPhase 3CXLNCT03080077
Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia
A Phase 3 study testing Ricrolin+ and Epi-Off in people with Keratoconus and Ectasia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL)… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Keratoconus, Ectasia
- What is being tested?
- Ricrolin+ and Epi-Off
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2019
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 10 years of age or older
- Understand and have signed written IRB-approved informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Having a diagnosis of keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
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- Presence of one or more slit lamp findings associated with keratoconus, such as:
- Scissoring of the retinoscopic reflex
- Fleischer ring
- Vogt striae
- Corneal thinning
- Corneal scarring
- BSCVA 20/20 or worse (<58 letters on ETDRS chart).
- Contact lens wearers only: Removal of contact lenses for the required period of time prior to the first refraction:
- Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks Hybrid lenses (SynergEyes; Rose K; Clear Kone) 2 Weeks Scleral Lenses 2 Weeks
- Exclusion Criteria: All subjects meeting any of the following criteria will be excluded from the study:
- A history of previous corneal surgery in the eye to be treated (including previous CXL treatment)
- Eyes with episodes of hydrops or scarring from hydrops may be included as long as there is no active inflammation
- Corneal pachymetry < 400 microns at the thinnest point measured by Pentacam
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- Clinically significant corneal scarring in the treatment zone
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- Pregnancy (including plan to become pregnant) or lactation during the procedure
- A known sensitivity to study medications
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study
- Inability to cooperate with diagnostic tests or inability to understand the informed consent.
- Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea without need for removal of the corneal epithelium. Patients will be randomized to receive CXL treatment with either the Epi-On or Epi-Off technique.
- Conditions
- Keratoconus, Ectasia
- Being tested
- Ricrolin+, Epi-Off
- 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.
Ricrolin+Drug
Also called Epi-on (iontophoresis)
The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.
Epi-OffDrug
Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.
| Study group | Role | What they receive |
|---|---|---|
| Epi-Off CXL | Active comparator | Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure. Receives: Drug: Epi-Off |
| Epi-On CXL | Experimental | The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea. Receives: Drug: Ricrolin+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kmax
Kmax = maximum simulated keratometry value
Measured: baseline and 2 years
Secondary outcomes (8)
Change in steepest K
steepest K is the higher diopter number which represents the steepest meridian of the cornea
Measured: baseline and 2 years
Change in astigmatism
Astigmatism is an imperfection in the curvature of the cornea, causing a refractive error diagnosed by standard eye exam with refraction test.
Measured: baseline and 2 years
Change in keratometry
Keratometry is the measurement of the corneal radius of curvature
Measured: baseline and 2 years
Change in pachymetry
Pachymetry is a common test for glaucoma and measures the thickness of the cornea
Measured: baseline and 2 years
Changes in curvature
Shape of cornea
Measured: baseline and 2 years
Change in sphere
Change in refraction
Measured: baseline and 2 years
Change in cylinder
Cylinder is the amount of astigmatism that is present
Measured: 2 years
Change in BCVA
Best-corrected visual acuity (BCVA)
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Penny Asbell, Icahn School of Medicine at Mount Sinai
- Investigators
- Penny A Asbell, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080077
- Sponsor's protocol ID
- GCO 16-0627
- Acronym
- CXL
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lombardo M, Serrao S, Rosati M, Ducoli P, Lombardo G. Biomechanical changes in the human cornea after transepithelial corneal crosslinking using iontophoresis. J Cataract Refract Surg. 2014 Oct;40(10):1706-15. doi: 10.1016/j.jcrs.2014.04.024.
PubMed 25263041Koller T, Schumacher S, Fankhauser F 2nd, Seiler T. Riboflavin/ultraviolet a crosslinking of the paracentral cornea. Cornea. 2013 Feb;32(2):165-8. doi: 10.1097/ICO.0b013e318269059b.
PubMed 23187160