- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03990506
Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus
Comparison of Epi-off and Epi-on Photorefractive Intrastromal Crosslinking (PiXL) for Progressive Keratoconus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a prospective, single-masked intraindividually comparing randomized clinical 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 32 participants with bilateral Keratoconus, receiving Epi-off PiXL (n=32) in one eye and Epi-on PiXL in high oxygen environment (n=32) in the fellow eye. The participants are randomized to epi-on PiXL utilizing block randomization with a sample size of 16 in each block; 16 right eyes and 16 left eyes. All participants 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 using Schemipflug camera measurements, Pentacam HR® (Oculus, Inc. Lynnwood, WA).
Endothelial cellcount is assessed (SP-2000P, Topcon, Inc) 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 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 and slit-lamp examination are evaluated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sofie Näslund
- Email: sofie.naslund@umu.se
Study Locations
-
-
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Umeå, Sweden, 901 85
- Department of Clinical Sciences/Ophthalmology, Umeå University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epi-on PiXL
Photorefractive intrastromal corneal crosslinking without epithelium debridement during humidified high oxygen flow.
|
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.
|
Active Comparator: Epi-off PiXL
Photorefractive intrastromal corneal crosslinking with epithelium debridement.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal keratometry (Kmax)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Kmax assessed with the Pentacam HR Scheimpflug camera, Diopters.
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Ocular Discomfort Scores
Time Frame: 4 hours, 8 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days after treatment
|
Subjective Ocular Discomfort Scores, Visual Analog Score (0 (no discomfort) - 10 (maximum discomfort)) for each eye, mm.
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4 hours, 8 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days after treatment
|
Uncorrected distance visual acuity (UDVA)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Change from baseline in distance uncorrected visual acuity, LogMAR
|
1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Best corrected visual acuity (BCVA)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Change from baseline in distance best corrected visual acuity, LogMAR
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Mean keratometry (Kmean)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Kmean (average) assessed with the Pentacam HR Scheimpflug camera, Diopters.
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Low contrast visual acuity (LCVA)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in low contrast visual acuities at 10 % and 2.5 % contrast, LogMAR
|
1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Manifest spherical equivalent (MRSE)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in spherical equivalent on subjective distance refraction, Diopters
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Central corneal thickness (CCT)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in central corneal thickness assessed with Pentacam, Scheimpflug camera, μm.
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in ocular wavefront aberrometry
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in higher order aberrations assessed with iTrace, Root mean square.
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1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Endothelial cell density (ECC)
Time Frame: 24 months after treatment
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Change from baseline in endothelial cell density, cells/mm2
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24 months after treatment
|
Intraocular pressure (IOP)
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months after treatment
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Change from baseline in intraocular pressure assessed with Goldmann applanation tonometry, mmHg.
|
1 month, 3 months, 6 months, 12 months and 24 months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Behndig, MD, PhD, Department of Clinical Sciences/Ophthalmology, Umeå University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PiXLKC-I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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