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

NCT ID: NCT03080077

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Keratoconus; Ectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Epi-Off

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Ricrolin+

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Epi-on (iontophoresis)

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Penny Asbell

Professor of Ophthalmology, Director of Cornea and Refractive Services, Director of the Cornea Fellowship Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Penny A Asbell, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25263041 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23187160 (View on PubMed)

Other Identifiers

GCO 16-0627

Identifier Type: -

Identifier Source: org_study_id