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PiXL for Correction of Hyperopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805425
Recruitment Status : Unknown
Verified May 2019 by Gemini Eye Clinic.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2019
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Gemini Eye Clinic

Study Description
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Brief Summary:
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.

Condition or disease Intervention/treatment Phase
Hyperopia Radiation: PiXL Not Applicable

Detailed Description:
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Radiation: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Uncorrected Distance Visual Acuity [ Time Frame: Month 12 ]
    Best distance visual acuity tested without any correction

  2. Change in Subjective Refraction [ Time Frame: Month 12 ]
    Spherical and cylindrical correction


Secondary Outcome Measures :
  1. Change in keratometry [ Time Frame: Month 12 ]
    Change in keratomery parameter K2-K1provided by Pentacam

  2. Change in Higher Order Aberrations [ Time Frame: Month 12 ]
    Higher Order Aberrations assessed using Pentacam

  3. Change in pachymetry [ Time Frame: Month 12 ]
    Change in mean cornea thickness in 8.0 mm ring provided by Pentacam

  4. Subjective questionnaire score [ Time Frame: Month 12 ]
    Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.

  5. Change in Corrected Distance Visual Acuity [ Time Frame: Month 12 ]
    Best distance visual acuity tested with the best correction

  6. Change in Spherical aberration [ Time Frame: Month 12 ]
    Spherical aberration assessed using Pentacam


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805425


Locations
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Czechia
Gemini Eye Clinic
Zlín, Czechia, 760 01
Sponsors and Collaborators
Gemini Eye Clinic
Investigators
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Principal Investigator: Pavel Stodulka, MD, PhD Gemini Eye Clinic
More Information
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Publications:

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Responsible Party: Gemini Eye Clinic
ClinicalTrials.gov Identifier: NCT03805425    
Other Study ID Numbers: PiXLHyperopia
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gemini Eye Clinic:
Hypeorpia
Crosslinking
PiXL
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases