Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2019 |
| Start Date: | November 2011 |
| End Date: | February 2020 |
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.
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.
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
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
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.
We found this trial at
1
site
Teaneck, New Jersey 07666
Principal Investigator: Peter S Hersh, MD
Phone: 201-883-0505
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