Epi-on PiXL for the Treatment of Progressive Keratoconus.
Primary Purpose
Keratoconus, Corneal Crosslinking, Corneal Densitometry
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Epi-on PiXL in high oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
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
Sites / Locations
- Umeå University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epi-on PiXL in high oxygen
Arm Description
Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow.
Outcomes
Primary Outcome Measures
Uncorrected Distance Visual Acuity (UDVA)
Change from baseline in Uncorrected Distance Visual Acuity
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
Secondary Outcome Measures
Subjective Ocular Discomfort Scores
Change in a Ocular Discomfort Visual Analogous Scale after treatment.
Manifest Refractive Spherical Equivalent (MRSE)
Change from baseline in Manifest Refractive Spherical Equivalent
Corneal Endothelial cell density (ECC)
Change from baseline in corneal endothelial cell density
Best Spectacle Distance Visual Acutiy (BSCVA)
Change from baseline in Best Spectacle Distance Visual Acutiy
Full Information
NCT ID
NCT04668924
First Posted
December 9, 2020
Last Updated
June 7, 2021
Sponsor
Umeå University
Collaborators
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04668924
Brief Title
Epi-on PiXL for the Treatment of Progressive Keratoconus.
Official Title
Prospective Evaluation of Photorefractive Intrastromal Crosslinking (PiXL) Without Epithelium Debridement (Epi-on) in High Oxygen for Progressive Keratoconus.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Corneal Crosslinking, Corneal Densitometry, Scheimpflug Photography, Corneal Disorder, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epi-on PiXL in high oxygen
Arm Type
Experimental
Arm Description
Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow.
Intervention Type
Procedure
Intervention Name(s)
Epi-on PiXL in high oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity (UDVA)
Description
Change from baseline in Uncorrected Distance Visual Acuity
Time Frame
1, 3, 6, 12 and 24 months after treatment.
Title
Keratometry readings
Description
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
Time Frame
1, 3, 6, 12 and 24 months after treatment
Secondary Outcome Measure Information:
Title
Subjective Ocular Discomfort Scores
Description
Change in a Ocular Discomfort Visual Analogous Scale after treatment.
Time Frame
4, 8h and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Title
Manifest Refractive Spherical Equivalent (MRSE)
Description
Change from baseline in Manifest Refractive Spherical Equivalent
Time Frame
1, 3, 6, 12 and 24 months after treatment.
Title
Corneal Endothelial cell density (ECC)
Description
Change from baseline in corneal endothelial cell density
Time Frame
12 and 24 months after treatment
Title
Best Spectacle Distance Visual Acutiy (BSCVA)
Description
Change from baseline in Best Spectacle Distance Visual Acutiy
Time Frame
1, 3, 6, 12 and 24 months after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Behndig, MD, PhD
Phone
+46707827536
Email
anders.behndig@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie Näslund
Email
sofie.naslund@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Behndig
Organizational Affiliation
Department of Clinical Sciences/Ophthalmology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umeå University Hospital
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Behndig, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Epi-on PiXL for the Treatment of Progressive Keratoconus.
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