Corneal Uptake of Riboflavin Eye Drops

Status Completed

Clinical Trial Summary

The overall objective of this study is to optimise the corneal cross-linking standard protocol in terms of a more economical use of the resource "medical personnel" and in terms of increased patient participation. If it can be shown that the riboflavin necessary for corneal cross-linking does not necessarily have to be applied directly on the cornea (as currently performed by the nurses), but can also be applied in the inferior fornix (as it would be performed by patients in the context of self-application), then it would be conceivable to transfer this task from medical staff to the patients.

Clinical Trial Description

This national single-centre, experimental, randomized and controlled trial will comprise two parallel arms. The intervention to be studied will be an alternative application of riboflavin drops in the inferior fornix. As comparator serves a conventional riboflavin drop application directly on the center of the cornea. Our research hypothesis is that the application of riboflavin drops in the inferior fornix is not inferior to the corneal application with respect to the resulting riboflavin concentrations in the anterior chamber; which represents a sufficient corneal impregnation with riboflavin. This study is randomized but not blinded. Recruitment is anticipated to start in September 2019 and is scheduled to last 1-2 months. We will enroll 12 patients in each trial arm. ;

Study Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT04062435
Study type	Interventional
Source	Luzerner Kantonsspital
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2019
Completion date	March 1, 2020

View Details

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	`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