Corneal Uptake of Riboflavin Eye Drops

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Ophthalmology, Lucerne Cantonal Hospital

Lucerne, 6004, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy clinical staff members of the Dept. of Ophthalmology at the Lucerne Cantonal Hospital will be evaluated for study inclusion.
Signed written informed consent form

Exclusion criteria

Aged < 18 years
Any ocular or systemic diseases with ocular side effects
Medication with potential ocular side effects
Epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration

Treatment and study plan

Drop application in the inferior fornix

Drug

See Arms

Drop application on the cornea

Drug

See Arms

Primary outcomes

Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)

Time frame: Three hours

Correlating to our standard CXL protocol, the application phase lasts 60 min and the riboflavin drops will be applied by the principle investigator every 5 minutes on the cornea in the conventional and in the inferior fornix in the interventional group. The drop application will be performed in an upright position and without an eyelid speculum. During the application phase, fluorophotometric measurements will be repeated every 15 minutes and changes in corneal and anterior chamber riboflavin concentrations will be documented.

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 20, 2019
Registry last updated: Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed