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Epi-on PiXL for the Treatment of Progressive Keratoconus.

NCT04668924 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Keratoconus
  • Corneal Crosslinking
  • Corneal Densitometry
  • Scheimpflug Photography
  • Corneal Disorder
  • Eye Diseases

Interventions

PROCEDURE

Epi-on PiXL in high oxygen

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.

Sponsors & Collaborators

  • Glaukos Corporation

    collaborator INDUSTRY

  • Umeå University

    lead OTHER

Principal Investigators

  • Anders Behndig · Department of Clinical Sciences/Ophthalmology, Umeå University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2026-02-05
Completion
2026-02-05

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668924 on ClinicalTrials.gov