Keratoconus Clinical Trial
— CXLOfficial title:
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia
Verified date | February 2023 |
Source | Cornea and Laser Eye Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cornea and Laser Eye Institute | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Cornea and Laser Eye Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum keratometry | 1 year | ||
Secondary | Best Corrected Visual Acuity | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04570020 -
Scleral Lens Fitting Using Wide-Field OCT
|
||
Recruiting |
NCT02921009 -
McNeel Eye Center Corneal Crosslinking Study
|
N/A | |
Completed |
NCT01691651 -
Botulinum Toxin A for the Treatment of Keratoconus
|
N/A | |
Terminated |
NCT02762253 -
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.
|
Phase 2 | |
Completed |
NCT01527708 -
Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas
|
N/A | |
Completed |
NCT01527721 -
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus
|
N/A | |
Recruiting |
NCT00841386 -
Treatment of Keratoconus Using Collagen Cross-Linking
|
Phase 2/Phase 3 | |
Completed |
NCT00347074 -
A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients
|
N/A | |
Completed |
NCT03187912 -
Accelerated Corneal Cross-linking With Different Riboflavin Solutions
|
Phase 3 | |
Completed |
NCT00584285 -
Corneal Topographer Fluorescein Patterns
|
||
Completed |
NCT03511495 -
Reliability of Topography Measurements in Keratoconus
|
||
Not yet recruiting |
NCT05395650 -
Cyanocobalamin as Photosensitizing Agent
|
||
Completed |
NCT04418999 -
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
|
Early Phase 1 | |
Completed |
NCT03235856 -
Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
|
||
Completed |
NCT05019768 -
Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
|
N/A | |
Withdrawn |
NCT01789333 -
Higher Irradiance in Keratoconus Ectasia
|
N/A | |
Completed |
NCT05114928 -
Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
|
||
Completed |
NCT03647046 -
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus
|
N/A | |
Recruiting |
NCT04439552 -
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
|
||
Recruiting |
NCT06100939 -
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
|
Phase 3 |