NCT03041883|Recruiting
Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting
CXL-KPro
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CXL-KPro
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 4, 2017
Actual (reported)Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting (keratolysis or sterile necrosis).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2017
Actual (reported)January 25, 2017
Actual (reported)February 3, 2017
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
1 day
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
1 week
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
2 weeks
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
This visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
1 month
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
Comparison of the rates of infectious keratitis between the groups
1 day
Comparison of the rates of infectious keratitis between the groups
1 week
Comparison of the rates of infectious keratitis between the groups
2 weeks
Comparison of the rates of infectious keratitis between the groups
1 month
Comparison of the rates of infectious keratitis between the groups
3 months
Patient will receive a crosslinked corneal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then one drop of riboflavin 0.1%/dextran 20% will be applied to 3 minutes on the de-epithelialized cornea for 15 minutes. Then, the source of ultraviolet A (UVA) will be irradiating the cornea for 30 minutes with a wavelength of 370 nanometer(nm) length with 5.4 joules(J)/ square centimeter (cm2) and 3 milliwatts(mW)/cm2. Meanwhile, the instillation of a drop of 0.1% riboflavin/dextran 20% continues every 5 minutes. Goggles against UVA are mandatory. The crosslinked graft-support will be forwarded to the surgeon according to standard procedure.
Patient wil receive a normal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then, one drop of riboflavin 0.1% / dextran 20% will be applied to 30 secondes for 5 minutes on the de-epithelialized cornea.The minimally manipulated normal graft-support will be forwarded to the surgeon according to standard procedure.
Corneal graft support for the KPro will be crosslinked and used with the standard surgical technique
Corneal graft-support will be de-epithelialized and soaked with riboflavin and then used with the standard surgical technique
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X3E4, Canada
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.
Marie-Claude Robert, MD
Centre hospitalier de l'Université de Montréal (CHUM)
First Submitted
January 25, 2017
First Posted
February 3, 2017
Study Start
January 4, 2017
Actual (reported)Primary Completion
January 2028
EstimatedAn imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.
1 month
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
3 months
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
These visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
Every 2-4 months depending on the judgment of the surgeon for at least 5 years
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.
1 year
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.
2 years
Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button
An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.
5 years
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 28, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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