Status:
UNKNOWN
PiXL as a Treatment for Low Grade Myopia
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Glaukos Corporation
Conditions:
Myopia
Refractive Errors
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
To assess the improvement in myopia with phototherapeutic intrastromal corneal collagen cross-linking (PiXL) without epithelial debridement (epi-on) in high oxygen environment for low grade myopia. Th...
Detailed Description
The study design is a prospective, single-masked intraindividually comparing randomized controlled trial, conducted at the Department of Clinical Sciences / Ophthalmology, Umeå University Hospital, Um...
Eligibility Criteria
Inclusion
- Spherical equivalent on distance subjective refraction between -0.50D and -2.50D.
- Astigmatism ≤ 0.75D
- Stable myopia. Maximum change in refraction of 0.50D in the last 2 years.
- Best corrected visual acuity of at least 0.00 logMAR (ETDRS chart).
- Thinnest pachymetry reading ≥ 440 μm.
- No previous ocular surgery.
- No cognitive insufficiency interfering with the informed consent.
Exclusion
- History of or current condition, disease, surgery or medication with ocular effects that could affect the outcomes of the treatment.
- Allergy to any substance or device used in the study.
- Cognitive insufficiency interfering with the informed consent
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04663048
Start Date
February 7 2019
End Date
June 17 2024
Last Update
December 20 2023
Active Locations (1)
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1
Umeå University Hospital
Umeå, Sweden, 90185