KeratoconusNCT04668924
Epi-on PiXL for the Treatment of Progressive Keratoconus.
A study testing Epi-on PiXL in high oxygen in people with Keratoconus and Corneal Crosslinking, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Keratoconus, Corneal Crosslinking, Corneal Densitometry
- What is being tested?
- Epi-on PiXL in high oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 20 Mar 2019to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Age under 18 or over 35
- Any corneal abnormalities except keratoconus
- Pregnancy or lactation
- Previous ocular surgery
- Cognitive insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Photorefractive Intrastromal Crosslinking (PiXL) Without Epithelium Debridement (Epi-on) in High Oxygen for Progressive Keratoconus.
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.
Read the 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
- Being tested
- Epi-on PiXL in high oxygen
- Medical subject headings
- Keratoconus, Corneal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi-on PiXL in high oxygenProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Epi-on PiXL in high oxygen | Experimental | Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow. Receives: Procedure: Epi-on PiXL in high oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity (UDVA)
Change from baseline in Uncorrected Distance Visual Acuity
Measured: 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
Measured: 1, 3, 6, 12 and 24 months after treatment
Secondary outcomes (4)
Subjective Ocular Discomfort Scores
Change in a Ocular Discomfort Visual Analogous Scale after treatment.
Measured: 4, 8h and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Manifest Refractive Spherical Equivalent (MRSE)
Change from baseline in Manifest Refractive Spherical Equivalent
Measured: 1, 3, 6, 12 and 24 months after treatment.
Corneal Endothelial cell density (ECC)
Change from baseline in corneal endothelial cell density
Measured: 12 and 24 months after treatment
Best Spectacle Distance Visual Acutiy (BSCVA)
Change from baseline in Best Spectacle Distance Visual Acutiy
Measured: 1, 3, 6, 12 and 24 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start20 Mar 2019
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Glaukos Corporation
- Responsible party
- Sponsor
- Investigators
- Anders Behndig, Principal investigator, Department of Clinical Sciences/Ophthalmology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668924
- Sponsor's protocol ID
- PIXLKC-II
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Photorefractive Intrastromal Crosslinking (PiXL) Without Epithelium Debridement (Epi-on) in High Oxygen for Progressive Keratoconus.
- ClinicalTrials.gov ID
- NCT04668924
- Acronym / sponsor ID
- PIXLKC-II
- Conditions
- Keratoconus, Corneal Crosslinking, Corneal Densitometry, Scheimpflug Photography, Corneal Disorder, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Glaukos Corporation
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epi-on PiXL in high oxygen | Experimental | Procedure: Epi-on PiXL in high oxygenPhotorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Age under 18 or over 35
- Any corneal abnormalities except keratoconus
- Pregnancy or lactation
- Previous ocular surgery
- Cognitive insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epi-on PiXL in high oxygenAfter 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. | Procedure or surgery | Epi-on PiXL in high oxygen |
Primary outcome
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 1, 3, 6, 12 and 24 months after treatment.
Change from baseline in Uncorrected Distance Visual Acuity
Keratometry readings
Time frame: 1, 3, 6, 12 and 24 months after treatment
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
4 secondary outcomes
Subjective Ocular Discomfort Scores
Time frame: 4, 8h and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Manifest Refractive Spherical Equivalent (MRSE)
Time frame: 1, 3, 6, 12 and 24 months after treatment.
Corneal Endothelial cell density (ECC)
Time frame: 12 and 24 months after treatment
Best Spectacle Distance Visual Acutiy (BSCVA)
Time frame: 1, 3, 6, 12 and 24 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Behndig principal investigator
Department of Clinical Sciences/Ophthalmology, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epi-on PiXL in high oxygen in people with Keratoconus and Corneal Crosslinking, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Distance Visual Acuity (UDVA) (time frame: 1, 3, 6, 12 and 24 months after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.