Prospective Evaluation of Photorefractive Intrastromal Crosslinking (PiXL) Without Epithelium Debridement (Epi-on) in High Oxygen for Progressive Keratoconus.
Sponsor study identifier
interventional
32
1 country
1
Study Start
March 20, 2019
Actual (reported)Primary Completion
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by individually customized Photorefractive intrastromal crosslinking (PiXL) without epithelium debridement in high oxygen environment (Epi-on) for progressive Keratoconus.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
March 20, 2019
Actual (reported)December 9, 2020
Actual (reported)December 16, 2020
Actual (reported)February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Uncorrected Distance Visual Acuity (UDVA)
Change from baseline in Uncorrected Distance Visual Acuity
1, 3, 6, 12 and 24 months after treatment.
Keratometry readings
Change from baseline in Keratometry readings, Kmean (average), K1 (flat meridian), K2 (steep meridian) and Kmax (steepest radius of curvature) assessed with the Pentacam HR Scheimpflug camera
1, 3, 6, 12 and 24 months after treatment
Subjective Ocular Discomfort Scores
4, 8h and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow.
After local anaesthetics, the keratoconus cornea is soaked in Riboflavin by repeated topical application during 10 minutes. A Riboflavin soaked sponge is used to lightly disrupt the epithelium tight junctions, without epithelium debridement. The cornea is illuminated with PiXL under 16:40 minutes during continuously delivery of humidified high oxygen via specific oxygen googles. The UV-dosage is individually customized based upon Kmax; for \< 45 Diopters (D) 7.2J/cm\^2 will be used; for 45-50D 10J/cm\^2 will be used; for \> 50D 15 J/cm\^2 will be used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Umeå University Hospital
Umeå, 90185, Sweden
Anders Behndig
Department of Clinical Sciences/Ophthalmology, Umeå University
32 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2020
First Posted
December 16, 2020
Study Start
March 20, 2019
Actual (reported)Pocket Versus Tunnel ICRS for Treatment of Keratoconus
Manifest Refractive Spherical Equivalent (MRSE)
1, 3, 6, 12 and 24 months after treatment.
Corneal Endothelial cell density (ECC)
12 and 24 months after treatment
Best Spectacle Distance Visual Acutiy (BSCVA)
1, 3, 6, 12 and 24 months after treatment.
Contact the study team to confirm eligibility.
Primary Completion
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 20, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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