Corneal Uptake of Riboflavin Eye Drops

Luzerner Kantonsspital

Status: Completed

Conditions: Keratoconus

Treatments: Drug: Drop application in the inferior fornix; Drug: Drop application on the cornea

Study type: Interventional

Funder types: Other

Identifiers

NCT04062435

KCI_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Interventional Group

Experimental group

Description:

Peschke®TE 0.25 % application in the INFERIOR FORNIX Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.

Treatment:

Drug: Drop application in the inferior fornix

Control Group

Active Comparator group

Description:

Peschke®TE 0.25 % application on the CORNEA Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.

Treatment:

Drug: Drop application on the cornea