Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04905108
Other study ID # TE-CXL-002
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 2, 2021
Est. completion date December 2025

Study information

Verified date December 2022
Source Cornea and Laser Eye Institute
Contact BethAnn Furlong-HIbbert
Phone (201) 692-9434
Email bfurlong-hibbert@vision-institute.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Corneal collagen crosslinking (CXL) has been demonstrated 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. 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 and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.


Description:

The objective of this randomized 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 two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared 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, and slit lamp examination.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - 12 years of age or older - Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK]) - Presence of central or inferior steepening on the Pentacam map - Axial topography consistent with keratoconus or post-surgical corneal ectasia - Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction - Signed written informed consent - Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: - Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme - Corneal pachymetry measuring 300 microns or less 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, for example: 1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) 2. Clinically significant corneal scaring in the CXL treatment zone - A 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Riboflavin
Administration of riboflavin one drop every 2 minutes during UVA exposure
Riboflavin
Administration of riboflavin one drop every 10 minutes during UVA exposure

Locations

Country Name City State
United States Cornea and Laser Eye Institute, Hersh Vision Group Teaneck New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Cornea and Laser Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum keratometry The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2. 12 months
Secondary Mean keratometry The change in mean keratometry (Mean K) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2. 1 year
See also
  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