Corneal Uptake of Riboflavin Eye Drops

NCT04062435 | Completed DMC

• 1 other identifier: KCI_02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratoconus

Keywords

Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master

Outcome Measures

Primary Outcomes (1)

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

  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.

  Three hours

Study Arms (2)

Interventional Group

EXPERIMENTAL

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.

Drug: Drop application in the inferior fornix

Control Group

ACTIVE COMPARATOR

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.

Drug: Drop application on the cornea

Interventions

Drop application in the inferior fornix DRUG

See Arms

Interventional Group

Drop application on the cornea DRUG

See Arms

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Dept. of Ophthalmology, Lucerne Cantonal Hospital

Lucerne, 6004, Switzerland

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Katja Iselin, MD

  Dept. of Ophthalmology, Lucerne Cantonal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 20, 2019
• Study Start: December 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)