Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia (CXL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080077
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Penny Asbell, Icahn School of Medicine at Mount Sinai

Brief 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) 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.

Condition or disease Intervention/treatment Phase
Keratoconus Ectasia Drug: Ricrolin+ Drug: Epi-Off Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Epi-Off CXL
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.
Drug: Epi-Off
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.

Experimental: Epi-On CXL
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.
Drug: Ricrolin+
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.
Other Name: Epi-on (iontophoresis)




Primary Outcome Measures :
  1. Change in Kmax [ Time Frame: baseline and 2 years ]
    Kmax = maximum simulated keratometry value


Secondary Outcome Measures :
  1. Change in steepest K [ Time Frame: baseline and 2 years ]
    steepest K is the higher diopter number which represents the steepest meridian of the cornea

  2. Change in astigmatism [ Time Frame: baseline and 2 years ]
    Astigmatism is an imperfection in the curvature of the cornea, causing a refractive error diagnosed by standard eye exam with refraction test.

  3. Change in keratometry [ Time Frame: baseline and 2 years ]
    Keratometry is the measurement of the corneal radius of curvature

  4. Change in pachymetry [ Time Frame: baseline and 2 years ]
    Pachymetry is a common test for glaucoma and measures the thickness of the cornea

  5. Changes in curvature [ Time Frame: baseline and 2 years ]
    Shape of cornea

  6. Change in sphere [ Time Frame: baseline and 2 years ]
    Change in refraction

  7. Change in cylinder [ Time Frame: 2 years ]
    Cylinder is the amount of astigmatism that is present

  8. Change in BCVA [ Time Frame: baseline and 2 years ]
    Best-corrected visual acuity (BCVA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. 10 years of age or older
  2. Understand and have signed written IRB-approved informed consent
  3. Willingness and ability to comply with schedule for follow-up visits
  4. Having a diagnosis of keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
  5. Presence of central or inferior steepening on the Pentacam map
  6. Axial topography consistent with keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
  7. Presence of one or more slit lamp findings associated with keratoconus, such as:

    1. Scissoring of the retinoscopic reflex
    2. Fleischer ring
    3. Vogt striae
    4. Corneal thinning
    5. Corneal scarring
  8. BSCVA 20/20 or worse (<58 letters on ETDRS chart).
  9. 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:

  1. 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

  2. Corneal pachymetry < 400 microns at the thinnest point measured by Pentacam
  3. 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:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
    2. Clinically significant corneal scarring in the treatment zone
  4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  5. Pregnancy (including plan to become pregnant) or lactation during the procedure
  6. A known sensitivity to study medications
  7. Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
  8. A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
  9. 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
  10. Inability to cooperate with diagnostic tests or inability to understand the informed consent.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080077


Locations
Layout table for location information
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Penny A Asbell, MD Icahn School of Medicine at Mount Sinai

Publications:
Layout table for additonal information
Responsible Party: Penny Asbell, Professor of Ophthalmology, Director of Cornea and Refractive Services, Director of the Cornea Fellowship Program, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03080077     History of Changes
Other Study ID Numbers: GCO 16-0627
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents