Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia (CXL)
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:
NCT01112072
First received: April 26, 2010
Last updated: July 25, 2016
Last verified: July 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | 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: | Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of 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: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best Corrected Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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: NCT01112072
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112072
Locations
| United States, New Jersey | |
| Cornea and Laser Eye Institute | Recruiting |
| Teaneck, New Jersey, United States, 07666 | |
| Contact: Stacey Lazar 201-883-0505 info@vision-institute.com | |
| Principal Investigator: Peter Hersh, M.D. | |
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
| Principal Investigator: | Peter Hersh, M.D. | Cornea and Laser Eye Institute |
More Information
| Responsible Party: | Cornea and Laser Eye Institute |
| ClinicalTrials.gov Identifier: | NCT01112072 History of Changes |
| Other Study ID Numbers: | CLEI-Intacs-CXL |
| Study First Received: | April 26, 2010 |
| 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 cornea ultraviolet |
Additional relevant MeSH terms:
|
Corneal Diseases Keratoconus Dilatation, Pathologic Eye Diseases Pathological Conditions, Anatomical Riboflavin Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on September 27, 2016