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

NCT03990506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by comparing individually customized Photorefractive intrastromal crosslinking (PiXL) for progressive Keratoconus. The study compares two different protocols, PiXL with corneal epithelium debridement (Epi-off) and PiXL without epithelium debridement in high oxygen environment (Epi-on), with the hypothesis that Epi-on gives less postoperative ocular discomfort.

Conditions

  • Keratoconus
  • Corneal Crosslinking
  • Corneal Biomechanics
  • Corneal Densitometry
  • Scheimpflug Photography
  • Corneal Disease
  • Eye 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.

Sponsors & Collaborators

  • Glaukos Corporation

    collaborator INDUSTRY

  • Umeå University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2023-01-24
Completion
2023-01-24

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 NCT03990506 on ClinicalTrials.gov