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

Phase 3

• Conditions: Keratoconus; Ectasia
• Interventions: Drug: Epi-Off; Drug: Ricrolin+

• Registration Number: NCT03080077
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epi-Off CXL	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.
Epi-On CXL	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.

Primary Outcome Measures

Name	Time	Method
Change in Kmax	baseline and 2 years	Kmax = maximum simulated keratometry value

Secondary Outcome Measures

Name	Time	Method
Change in steepest K	baseline and 2 years	steepest K is the higher diopter number which represents the steepest meridian of the cornea
Changes in curvature	baseline and 2 years	Shape of cornea
Change in astigmatism	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.
Change in keratometry	baseline and 2 years	Keratometry is the measurement of the corneal radius of curvature
Change in pachymetry	baseline and 2 years	Pachymetry is a common test for glaucoma and measures the thickness of the cornea
Change in cylinder	2 years	Cylinder is the amount of astigmatism that is present
Change in BCVA	baseline and 2 years	Best-corrected visual acuity (BCVA)
Change in sphere	baseline and 2 years	Change in refraction

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States