NCT02349165

Brief Summary

The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

January 17, 2015

Last Update Submit

January 27, 2015

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Clinical stabilisation of keratoconus one year after CXL

    Using a Scheimpflug device (Pentacam, Oculus), topography measurements are performed. Clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value.

    1 year

Secondary Outcomes (1)

  • Complications, defined as epithelial healing problems and/or keratitis.

    1 year

Study Arms (2)

epithelium off CXL

ACTIVE COMPARATOR

epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)

Procedure: Transepithelial versus epithelium-off CXLDrug: Isotonic riboflavin

Ricrolin TE CXL

EXPERIMENTAL

Ricrolin-TE eye drops for 15 minutes (2 minute interval) and 15 minute Ricrolin TE pooled on the cornea using a silicone ring + 30 minutes ultraviolet-A irradiation (Ricrolin TE every 5 minutes).

Procedure: Transepithelial versus epithelium-off CXLDrug: Ricrolin TE

Interventions

Transepithelial versus epithelium-off CXLPROCEDURE

A comparison of the CXL procedure with and without epithelium removal

Also known as: epithelium-on versus epithelium-ff corneal crosslinking
Ricrolin TE CXLepithelium off CXL
Ricrolin TEDRUG

Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation

Ricrolin TE CXL
Isotonic riboflavinDRUG

After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation

epithelium off CXL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented progressive KC (by Pentacam and/or corneal topography imaging).
  • A clear central cornea.
  • A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
  • Minimal Snellen corrected distance visual acuity of ≥ 0.4.
  • Patient age of ≥ 18 years.
  • Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:
  • o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry
  • Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months

You may not qualify if:

  • Presence of corneal scars.
  • History of epithelial healing problems.
  • Presence of previous ocular infection (such as herpes keratitis).
  • Patients who are pregnant and/or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

    PMID: 32557558DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
BOptom

Study Record Dates

First Submitted

January 17, 2015

First Posted

January 28, 2015

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

NL(1)