Keratoconus Clinical Trial
Official title:
Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. Cross-linking has been shown increase the rigidity of the cornea. The patients would be treated once and then followed over 24 months. .
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 35 Years |
Eligibility |
Inclusion Criteria: - no prior history of ocular surgery - treatment eye must have a maximum corneal power of between 47 D and 60 diopters - corneal thickness must be greater than 400 µ - absence of corneal scarring - patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features: - high myopia - corneal ectasia as viewed by slit-lamp exam or measured by pachometry - Vogt's striae - topographic findings of superior flattening and inferior steepening of the cornea - presence of Fleischer ring Exclusion Criteria: - history of prior ocular surgery (history of contact lens use is not an exclusion criterion) - average corneal power > 60 D - presence of corneal scarring - corneal thickness 400 µ or less - history of herpes simplex virus keratitis - history of uveitis - pre-existing glaucoma |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fichte,Endl, & Elmer EyeCare | Amherst | New York |
United States | The Ira G. Ross Eye Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
University at Buffalo |
United States,
Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg — View Citation
Kohlhaas M, Spoerl E, Schilde T, Unger G, Wittig C, Pillunat LE. Biomechanical evidence of the distribution of cross-links in corneas treated with riboflavin and ultraviolet A light. J Cataract Refract Surg. 2006 Feb;32(2):279-83. — View Citation
Mazzotta C, Balestrazzi A, Traversi C, Baiocchi S, Caporossi T, Tommasi C, Caporossi A. Treatment of progressive keratoconus by riboflavin-UVA-induced cross-linking of corneal collagen: ultrastructural analysis by Heidelberg Retinal Tomograph II in vivo c — View Citation
Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. — View Citation
Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8. — View Citation
Natarajan R, Padmanabhan P, Guruswami S. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Sep;33(9):1503. — View Citation
Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. Review. — View Citation
Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. — View Citation
Wollensak G. Crosslinking treatment of progressive keratoconus: new hope. Curr Opin Ophthalmol. 2006 Aug;17(4):356-60. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best corrected visual acuity | 24 months | Yes | |
Primary | Spherical equivalent power of the cornea (Best spectacle refraction) | 24 months | No | |
Primary | KMax: the maximum corneal curvature | 24 months | Yes | |
Primary | Average corneal power of the cornea in the central 4 mm. | 24 months | No | |
Secondary | Corneal resistance factor. | 24 months | No | |
Secondary | Maximal posterior surface elevation of the cornea. | 24 months | No | |
Secondary | Apical corneal thickness. | 24 months | Yes | |
Secondary | Endothelial count. | 24 months | Yes |
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 | |
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 |
NCT05019768 -
Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
|
N/A | |
Completed |
NCT03235856 -
Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
|
||
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 | |
Completed |
NCT02444923 -
Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders
|
N/A |