Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by Cornea and Laser Eye Institute
Sponsor:
Cornea and Laser Eye Institute
Information provided by (Responsible Party):
Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:
NCT01464268
First received: November 1, 2011
Last updated: July 25, 2016
Last verified: July 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Keratoconus Corneal Ectasia |
Drug: Riboflavin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia |
Resource links provided by NLM:
MedlinePlus related topics:
Corneal Disorders
Drug Information available for:
Riboflavin
U.S. FDA Resources
Further study details as provided by Cornea and Laser Eye Institute:
Primary Outcome Measures:
- Maximum Keratometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Riboflavin without dextran
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464268
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464268
Contacts
| Contact: Stacey Lazar | 201-883-0505 | info@vision-institute.com |
Locations
| United States, New Jersey | |
| Cornea and Laser Eye Institute | Recruiting |
| Teaneck, New Jersey, United States, 07666 | |
| Contact: S Lazar 201-883-0505 info@vision-institute.com | |
| Principal Investigator: Peter S Hersh, MD | |
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
| Principal Investigator: | Peter Hersh, MD | Cornea and Laser Eye Institute |
More Information
Publications:
| Responsible Party: | Cornea and Laser Eye Institute |
| ClinicalTrials.gov Identifier: | NCT01464268 History of Changes |
| Other Study ID Numbers: | CLEI-EpiCXL |
| Study First Received: | November 1, 2011 |
| Last Updated: | July 25, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cornea and Laser Eye Institute:
|
Keratoconus Corneal Ectasia Collagen Crosslinking Riboflavin |
Additional relevant MeSH terms:
|
Keratoconus Dilatation, Pathologic Corneal Diseases Eye Diseases Pathological Conditions, Anatomical Riboflavin Dextrans Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents Anticoagulants Plasma Substitutes Blood Substitutes |
ClinicalTrials.gov processed this record on September 23, 2016