Epi-on PiXL for the Treatment of Progressive Keratoconus.

NCT ID: NCT04668924

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2026-02-05

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.

Detailed Description

The study is designed as a prospective, open-label, nonrandomized trial involving participants of both genders aged 18-35 years with Keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden.

The study includes 30 participants with unilateral Keratoconus, receiving Epi-on PiXL in high oxygen environment (n=30). All patients are informed about the procedures before consenting to participate in the study.

At baseline, before treatment, each eye is examined with slit-lamp microscopy, subjective refraction, determination of uncorrected (UCVA), low contrast visual acuity at 2.5 percentage contrast and 10 percentage contrast and best corrected (BSCVA) visual acuities using the LogMAR fast protocol and intraocular pressure (IOP) using Goldmann applanation tonometry. Under standardized, mesopic light conditions each eye is evaluated by keratometry readings and central corneal thickness, extracted from Schemipflug camera measurements, Pentacam HR® (Oculus, Inc. Lynnwood, WA) and AS-OCT (Fourier domain OCT CASIA2, Tomey Technology and vision, Germany).

Central corneal endothelial photographs are taken with the Topcon SP-IP specular microscope (Topcon Europe B.V., Capelle a/d Ijssel, the Netherlands) and total ocular wavefront is measured with iTrace (Tracey Technologies, Inc.).

Ocular discomfort is subjectively evaluated in each eye by a specific visual analogous rating scale at 4h, 8h, 12h, 24h and thereafter daily up to 1 week postoperatively.

All the above mentioned examinations are repeated at 1, 3, 6, 12 and 24 months after treatment. At 1 day and 1 week after treatment, solely UCVA, Auto refractor measurements, slit-lamp examination are evaluated.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epi-on PiXL in high oxygen

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

Group Type: EXPERIMENTAL

Epi-on PiXL in high oxygen

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• 18-35 years of age
• No ocular abnormalities except keratoconus
• No previous ocular surgery
• No cognitive insufficiency interfering with the informed consent.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Behndig

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Sciences/Ophthalmology, Umeå University

Locations

Umeå University Hospital

Umeå, , Sweden

Countries

Sweden

Other Identifiers

PIXLKC-II

Identifier Type: -

Identifier Source: org_study_id