Epi-on PiXL for the Treatment of Progressive Keratoconus.

NCT04668924 | Unknown

• 1 other identifier: PIXLKC-II
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Subjective Ocular Discomfort Scores

  4, 8h and 1, 2, 3, 4, 5, 6 and 7 days after treatment.

• 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.

Study Arms (1)

Epi-on PiXL in high oxygen

EXPERIMENTAL

Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow.

Procedure: Epi-on PiXL in high oxygen

Interventions

Epi-on PiXL in high oxygen PROCEDURE

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.

Epi-on PiXL in high oxygen

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients planned for corneal crosslinking.
• Progressive keratoconus documented with a consistent decrease of best corrected visual acuity with no other explanation, an unquestionable historical progression, or a progression documented with the Pentacam Scheimpflug camera with at least 2 of the following: progressive anterior and/or posterior corneal steepening and/or progressive corneal thinning and/or increased rate of corneal thickness change from the periphery to the center.
• A keratoconus diagnosis based on abnormal posterior elevation, abnormal corneal thickness distribution and clinical noninflammatory corneal thinning using the "Belin/Ambrósio enhanced ectasia" measurements of the Pentacam Scheimpflug camera.
• Minimum corneal thickness of 400 µm at the thinnest point before epithelial removal.
• years of age
• No ocular abnormalities except keratoconus
• No previous ocular surgery
• No cognitive insufficiency interfering with the informed consent.

You may not qualify if:

• Age under 18 or over 35
• Any corneal abnormalities except keratoconus
• Pregnancy or lactation
• Previous ocular surgery
• Cognitive insufficiency

Sponsors & Collaborators

• Umeå University: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Keratoconus; Corneal Diseases; Eye Diseases

Study Officials

• Anders Behndig

  Department of Clinical Sciences/Ophthalmology, Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: March 20, 2019
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)