Study Results
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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COMPLETED
NA
61 participants
INTERVENTIONAL
2011-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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epithelium off CXL
epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
Transepithelial versus epithelium-off CXL
A comparison of the CXL procedure with and without epithelium removal
Isotonic riboflavin
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
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).
Transepithelial versus epithelium-off CXL
A comparison of the CXL procedure with and without epithelium removal
Ricrolin TE
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
Interventions
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Transepithelial versus epithelium-off CXL
A comparison of the CXL procedure with and without epithelium removal
Ricrolin TE
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
Isotonic riboflavin
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of epithelial healing problems.
* Presence of previous ocular infection (such as herpes keratitis).
* Patients who are pregnant and/or breastfeeding.
18 Years
ALL
No
Sponsors
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Dr. F.P. Fischer Stichting
UNKNOWN
Stichting Nederlands Oogheelkundig Onderzoek
UNKNOWN
Nienke Soeters
OTHER
Responsible Party
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Nienke Soeters
BOptom
Locations
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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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.
Other Identifiers
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10-374
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL29961
Identifier Type: -
Identifier Source: org_study_id
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