NCT01464268

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Cornea and Laser Eye Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Corneal collagen crosslinking (CXL) has been proposed 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. During previous studies of the CXL procedure, the surface epithelial cells have been removed. 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 as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

Detailed description

The objective of this 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 riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups 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, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Conditions

• Keratoconus
• Corneal Ectasia

Interventions

Type	Name	Description
DRUG	Riboflavin	Administration of riboflavin every 2 minutes for the duration of UV exposure.
DRUG	Riboflavin	Administration of riboflavin every 1 minute for the duration of UV exposure.

Timeline

• Start date: 2011-11-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2011-11-03
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States