Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 30 of 67 for:    cornea AND cross-linking

Standard Versus Transepithelial Corneal Crosslinking

This study has been completed.
Sponsor:
Collaborators:
Dr. F.P. Fischer Stichting
Stichting Nederlands Oogheelkundig Onderzoek
Information provided by (Responsible Party):
Nienke Soeters, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02349165
First received: January 17, 2015
Last updated: January 27, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Keratoconus
Procedure: Transepithelial versus epithelium-off CXL
Drug: Ricrolin TE
Drug: Isotonic riboflavin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Clinical stabilisation of keratoconus one year after CXL [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Complications, defined as epithelial healing problems and/or keratitis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the incidence of epithelial healing problems after treatment will be recorded


Enrollment: 61
Study Start Date: May 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epithelium off CXL
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 CXL
A comparison of the CXL procedure with and without epithelium removal
Other Name: epithelium-on versus epithelium-ff corneal crosslinking
Drug: Isotonic riboflavin
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
Experimental: Ricrolin TE CXL
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 CXL
A comparison of the CXL procedure with and without epithelium removal
Other Name: epithelium-on versus epithelium-ff corneal crosslinking
Drug: Ricrolin TE
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02349165

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Nienke Soeters
Dr. F.P. Fischer Stichting
Stichting Nederlands Oogheelkundig Onderzoek
  More Information

No publications provided

Responsible Party: Nienke Soeters, BOptom, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02349165     History of Changes
Other Study ID Numbers: NL29961, 10-374
Study First Received: January 17, 2015
Last Updated: January 27, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Dutch Health Care Inspectorate

Additional relevant MeSH terms:
Corneal Diseases
Keratoconus
Eye Diseases
Riboflavin
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on March 03, 2015