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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ricrolin+ | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kmax | Kmax = maximum simulated keratometry value | baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in steepest K | steepest K is the higher diopter number which represents the steepest meridian of the cornea | 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. |
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Inclusion:
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)
Presence of one or more slit lamp findings associated with keratoconus, such as:
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)
a. 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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Penny A Asbell, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25263041 | Background | 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. | |
| 23187160 | Background | Koller 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. |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007478 | Iontophoresis |
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004586 | Electrophoresis |
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|
| Epi-Off | Drug | 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. |
|
| baseline and 2 years |
| Change in keratometry | Keratometry is the measurement of the corneal radius of curvature | baseline and 2 years |
| Change in pachymetry | Pachymetry is a common test for glaucoma and measures the thickness of the cornea | baseline and 2 years |
| Changes in curvature | Shape of cornea | baseline and 2 years |
| Change in sphere | Change in refraction | baseline and 2 years |
| Change in cylinder | Cylinder is the amount of astigmatism that is present | 2 years |
| Change in BCVA | Best-corrected visual acuity (BCVA) | baseline and 2 years |
| D055664 |
| Electrochemical Techniques |
| D008919 | Investigative Techniques |
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D010789 | Phototherapy |