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

Keratoconus Clinical Trial

— CXL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03080077
• Other study ID #: GCO 16-0627
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ectasia
• Keratoconus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Kmax	Kmax = maximum simulated keratometry value	baseline and 2 years
Secondary	Change in steepest K	steepest K is the higher diopter number which represents the steepest meridian of the cornea	baseline and 2 years
Secondary	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.	baseline and 2 years
Secondary	Change in keratometry	Keratometry is the measurement of the corneal radius of curvature	baseline and 2 years
Secondary	Change in pachymetry	Pachymetry is a common test for glaucoma and measures the thickness of the cornea	baseline and 2 years
Secondary	Changes in curvature	Shape of cornea	baseline and 2 years
Secondary	Change in sphere	Change in refraction	baseline and 2 years
Secondary	Change in cylinder	Cylinder is the amount of astigmatism that is present	2 years
Secondary	Change in BCVA	Best-corrected visual acuity (BCVA)	baseline and 2 years