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Status unknownNCT03805425Updated Feb 3, 2021

PiXL for Correction of Hyperopia

An interventional study of PiXL in Hyperopia, sponsored by Gemini Eye Clinic. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Gemini Eye Clinic · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.

Read the 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.

02

Conditions studied

  • Hyperopia

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Keywords

  • Hypeorpia
  • Crosslinking
  • PiXL
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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

Interventions

  • RadiationPiXL

    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.

05

What researchers measure

Primary outcomes

  1. Change in Uncorrected Distance Visual Acuity

    Best distance visual acuity tested without any correction

    Time frame: Month 12

  2. Change in Subjective Refraction

    Spherical and cylindrical correction

    Time frame: Month 12

Secondary outcomes

  1. Change in keratometry

    Change in keratomery parameter K2-K1provided by Pentacam

    Time frame: Month 12

  2. Change in Higher Order Aberrations

    Higher Order Aberrations assessed using Pentacam

    Time frame: Month 12

  3. Change in pachymetry

    Change in mean cornea thickness in 8.0 mm ring provided by Pentacam

    Time frame: Month 12

  4. Subjective questionnaire score

    Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.

    Time frame: Month 12

  5. Change in Corrected Distance Visual Acuity

    Best distance visual acuity tested with the best correction

    Time frame: Month 12

  6. Change in Spherical aberration

    Spherical aberration assessed using Pentacam

    Time frame: Month 12

06

Study locations

1 site
  • Gemini Eye Clinic
    Zlín, 760 01, Czechia
07

References and documents

Publications

  • 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. PubMed 25506204 ↗
08

Registry details

Key details

Study ID
NCT03805425
Lead sponsor
Gemini Eye Clinic
Responsible party
Sponsor
First posted
Jan 15, 2019
Start date
Dec 2016
Primary completion
Dec 2020
Completion
Mar 2021 (estimated)
Last update
Feb 3, 2021

Study contacts

Pavel Stodulka, MD, PhD
principal investigator · Gemini Eye Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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