Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 2, 2019

Primary Completion Date

January 24, 2023

Study Completion Date

January 24, 2023

Conditions
KeratoconusCorneal CrosslinkingCorneal BiomechanicsCorneal DensitometryScheimpflug PhotographyCorneal DiseaseEye Diseases
Interventions
PROCEDURE

Epi-on PiXL

Photorefractive intrastromal crosslinking (PiXL) After local anaesthetics, the cornea is soaked in Riboflavin by repeated topical application during 10 minutes. For masking purposes, epithelial debridement is simulated by moving a scraping instrument in front of the cornea. 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 goggles. The UV-dosage is individually customized based upon Kmax; \< 45D, 7.2J/cm2; 45-50D, 10J/cm2; \> 50D, 15 J/cm2.

PROCEDURE

Epi-Off PiXL

Photorefractive intrastromal crosslinking (PiXL) After local anaesthetics, the corneal epithelium is debrided and the cornea is soaked in Riboflavin by repeated topical application during 10 minutes. The cornea is then illuminated with individually customized topography-guided PiXL under 16:40 minutes. The UV-dosage is individually customized based upon Kmax; \< 45D, 7.2J/cm2; 45-50D, 10J/cm2; \> 50D, 15 J/cm2.

Trial Locations (1)

901 85

Department of Clinical Sciences/Ophthalmology, Umeå University, Umeå

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Glaukos Corporation

INDUSTRY

lead

Umeå University

OTHER

NCT03990506 - Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus | Biotech Hunter | Biotech Hunter