CXL: Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

Sponsor

Cornea and Laser Eye Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01112072

Collaborator

(none)

160

Enrollment

Location

Arms

152

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.

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

Detailed Description

The purpose of this is to ascertain the possible additive effect of the two treatments to both improve the quality of the corneal optics (i.e. improve corneal topography regularity) and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed, does improve corneal topography and improve contact lens tolerance and spectacle corrected visual acuity, as well as uncorrected visual acuity in some patients. Investigations of CXL have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this suggests a potential additive effect of the two on the patient's ultimate visual outcome. Thus, the patient would be afforded two potential benefits: (1) the potential of a more robust visual outcome and (2) stabilization of the keratoconic cornea on the longer term.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intacs combined with CXL Intacs placement followed by collagen crosslinking with UV light and riboflavin	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL. Other Names: Intracorneal Ring Segments Cornea Collagen Crosslinking
Active Comparator: Intacs followed by CXL Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL. Other Names: Intracorneal Ring Segments Cornea Collagen Crosslinking

Arm

Intervention/Treatment

Active Comparator: Intacs combined with CXL

Intacs placement followed by collagen crosslinking with UV light and riboflavin

Drug: Riboflavin

Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.

Other Names:

Intracorneal Ring Segments

Cornea Collagen Crosslinking

Active Comparator: Intacs followed by CXL

Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later

Drug: Riboflavin

Other Names:

Intracorneal Ring Segments

Cornea Collagen Crosslinking

Outcome Measures

Primary Outcome Measures

Maximum keratometry [1 year]

Secondary Outcome Measures

Best Corrected Visual Acuity [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

21 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)
Subjects who meet the manufacturer's nomogram recommendations for Intacs segments
Topography consistent with keratoconus or post-surgical corneal ectasia.
BSCVA worse than 20/20 (<55 letters on ETDRS chart)

Exclusion Criteria:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
History of corneal disease
History of chemical injury or delayed epithelial healing in the eye(s) to be treated.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.
Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.