Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2016-12-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Photorefractive intrastromal corneal crosslinking (PiXL)
Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea.
PiXL
The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
Interventions
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PiXL
The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
Eligibility Criteria
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Inclusion Criteria
* astigmatism up to 0.75 Dcyl
* corneal thickness above 400 µm
* endothelial cell density above 1500 cell/mm2
Exclusion Criteria
* any corneal pathology e.g. corneal scar or dystrophy
* unstable refraction
* patient not able to understand and sign informed consent
* patients with connective tissue disorder or uncontrolled diabetes
* pregnant or lactating women
* aphakic eyes or pseudophakic eyes without UV blocking IOL
18 Years
ALL
No
Sponsors
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Gemini Eye Clinic
INDUSTRY
Responsible Party
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Principal Investigators
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Pavel Stodulka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gemini Eye Clinic
Locations
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Gemini Eye Clinic
Zlín, , Czechia
Countries
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References
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Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
Other Identifiers
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PiXLHyperopia
Identifier Type: -
Identifier Source: org_study_id
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