Corneal Uptake of Riboflavin Eye Drops

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Group

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.

Group Type EXPERIMENTAL

Drop application in the inferior fornix

Intervention Type DRUG

See Arms

Control Group

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.

Group Type ACTIVE_COMPARATOR

Drop application on the cornea

Intervention Type DRUG

See Arms

Interventions

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Drop application in the inferior fornix

See Arms

Intervention Type DRUG

Drop application on the cornea

See Arms

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes