PiXL for Correction of Hyperopia
Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
1 other identifier
interventional
25
1 country
1
Brief Summary
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 3, 2021
May 1, 2019
4 years
January 10, 2019
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Uncorrected Distance Visual Acuity
Best distance visual acuity tested without any correction
Month 12
Change in Subjective Refraction
Spherical and cylindrical correction
Month 12
Secondary Outcomes (6)
Change in keratometry
Month 12
Change in Higher Order Aberrations
Month 12
Change in pachymetry
Month 12
Subjective questionnaire score
Month 12
Change in Corrected Distance Visual Acuity
Month 12
- +1 more secondary outcomes
Study Arms (1)
Photorefractive intrastromal corneal crosslinking (PiXL)
EXPERIMENTALPatients 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.
Interventions
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
You may qualify if:
- low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
- astigmatism up to 0.75 Dcyl
- corneal thickness above 400 µm
- endothelial cell density above 1500 cell/mm2
You may not qualify if:
- any prior corneal surgery or any eye surgery within the last 3 months,
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gemini Eye Clinic
Zlín, 760 01, Czechia
Related Publications (1)
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.
PMID: 25506204BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel Stodulka, MD, PhD
Gemini Eye Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 15, 2019
Study Start
December 1, 2016
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
February 3, 2021
Record last verified: 2019-05