Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Sponsor

Cornea and Laser Eye Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01464268

Collaborator

(none)

160

Enrollment

Location

Arms

133

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During previous studies of the CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Corneal Ectasia	Drug: Riboflavin Drug: Riboflavin	Phase 3

Detailed Description

The objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Riboflavin drops every minute Administration of riboflavin every 2 minutes for the duration of UV exposure.	Drug: Riboflavin Administration of riboflavin every 1 minute for the duration of UV exposure. Other Names: Riboflavin without Dextran
Active Comparator: Riboflavin drops every 2 minutes Administration of riboflavin every 1 minute for the duration of UV exposure.	Drug: Riboflavin Administration of riboflavin every 2 minutes for the duration of UV exposure. Other Names: Riboflavin without dextran

Arm

Intervention/Treatment

Active Comparator: Riboflavin drops every minute

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Drug: Riboflavin

Administration of riboflavin every 1 minute for the duration of UV exposure.

Other Names:

Riboflavin without Dextran

Active Comparator: Riboflavin drops every 2 minutes

Administration of riboflavin every 1 minute for the duration of UV exposure.

Drug: Riboflavin

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Other Names:

Riboflavin without dextran

Outcome Measures

Primary Outcome Measures

Maximum Keratometry [12 months]
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint, the change in maximum keratometry (Kmax) from baseline will be evaluated at 1, 3 and 6 month for all eyes

Secondary Outcome Measures

Manifest refraction [12 months]
The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As a secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3, and 6 months to look at the effect of wound healing on this variable.
Visual Acuity [12 months]
Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1, 3, and 6 months following the CXL procedure will be analyzed.
Endothelial cell density [12 months]
Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
Vision with contact lenses or glasses is worse than 20/20
Corneal thickness greater than 375 microns at the thinnest point

Exclusion Criteria:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
Clinically significant corneal scarring in the CXL treatment zone
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.