Keratoconus Clinical Trial
Official title:
Corneal Biomechanical Analysis Using Brillouin Microscopy
The objective of this study is to measure the Brillouin biomechanical properties in keratoconic corneas and characterize biomechanical alterations that occur after corneal procedures that inherently strengthen or weaken the cornea by evaluating the change in Brillouin metrics before and after treatments.
Surgical correction of myopia and keratoconus identification/management are separate but tightly intertwined issues of major significance. For both, there is an unmet need for direct measurements to evaluate corneal stiffness (i.e. its resistance to deformation). The prevalence of myopia is expected to double, affecting more than 50% of the US population, by 2050. Laser in situ keratomileusis (LASIK) is one of the most popular and successful surgeries in the world and compares favorably to long-term contact lens wear use for myopia correction. However, only ~10% of eligible patients undergo LASIK currently; the others cite safety concerns as a major factor in their decision. The primary risk for poor refractive surgery outcomes is biomechanical failure due to unidentified (subclinical) ectasia (i.e. keratoconus). Patients presenting for LASIK evaluation with atypical, suspicious corneal curvature but with undetermined true risk represent the leading reason for surgery screening failures. This results in good candidates being denied surgery, while up to 10% of truly poor candidates are still missed using current screening algorithms. Keratoconus is up to 10 times more prevalent than the previously reported 1/2000 figure. Corneal cross-linking (CXL) is now FDA approved in the US for keratoconus treatment and is effective at stiffening the cornea and halting ectasia progression. Early identification of keratoconus is critical, but current tests in the clinic are morphological, not biomechanical, and therefore do not allow a definitive diagnosis at the earliest stages resulting in vision loss before CXL treatment is initiated. Thus, the need for accurate identification of subclinical ectasia has never been greater. In the past years, newly developed technology, Brillouin microscopy, has emerged as the most promising tool to address this clinical need. This study will systemically address the critical gap in current knowledge by linking Brillouin mapping of corneal biomechanical alterations to abnormal morphological behavior and testing the findings in conditions where corneal biomechanics are abruptly altered, by: 1) weakening with refractive surgery procedures, and 2) strengthening through corneal cross-linking. It is anticipated that a clinical tool assessing the mechanical state of the cornea will improve early diagnosis and management of keratoconus as well as refractive surgery planning. Ultimately, this will lead to predictive models where Brillouin measurements could be an accurate predictor of postoperative outcomes and thus aid in developing individualized surgical parameters. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04570020 -
Scleral Lens Fitting Using Wide-Field OCT
|
||
Recruiting |
NCT02921009 -
McNeel Eye Center Corneal Crosslinking Study
|
N/A | |
Terminated |
NCT02762253 -
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.
|
Phase 2 | |
Completed |
NCT01691651 -
Botulinum Toxin A for the Treatment of Keratoconus
|
N/A | |
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 |