Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

Sponsor
Cornea and Laser Eye Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04905108
Collaborator
(none)
160
1
2
30
5.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols
Actual Study Start Date :
Jun 2, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Riboflavin drop every 2 minutes

Administration of one drop of Riboflavin every 2 minutes during UV exposure

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

Active Comparator: Riboflavin drop every 10 minutes

Administration of one drop of Riboflavin every 10 minutes during UV exposure

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

Outcome Measures

Primary Outcome Measures

  1. Maximum keratometry [12 months]

    The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

Secondary Outcome Measures

  1. Mean keratometry [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cornea and Laser Eye Institute, Hersh Vision Group Teaneck New Jersey United States 07666

Sponsors and Collaborators

  • Cornea and Laser Eye Institute

Investigators

  • Study Director: Peter S Hersh, MD, Cornea and Laser Eye Institute - Hersh Vision Group
  • Principal Investigator: Steven A Greenstein, MD, Cornea and Laser Eye Institute - Hersh Vision Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:
NCT04905108
Other Study ID Numbers:
  • TE-CXL-002
First Posted:
May 27, 2021
Last Update Posted:
Aug 30, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cornea and Laser Eye Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2021