PiXL for Correction of Hyperopia

February 2, 2021 updated by: Gemini Eye Clinic

Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Zlín, Czechia, 760 01
        • Gemini Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Uncorrected Distance Visual Acuity
Time Frame: Month 12
Best distance visual acuity tested without any correction
Month 12
Change in Subjective Refraction
Time Frame: Month 12
Spherical and cylindrical correction
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in keratometry
Time Frame: Month 12
Change in keratomery parameter K2-K1provided by Pentacam
Month 12
Change in Higher Order Aberrations
Time Frame: Month 12
Higher Order Aberrations assessed using Pentacam
Month 12
Change in pachymetry
Time Frame: Month 12
Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
Month 12
Subjective questionnaire score
Time Frame: Month 12
Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
Month 12
Change in Corrected Distance Visual Acuity
Time Frame: Month 12
Best distance visual acuity tested with the best correction
Month 12
Change in Spherical aberration
Time Frame: Month 12
Spherical aberration assessed using Pentacam
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemini Eye Clinic

Investigators

  • Principal Investigator: Pavel Stodulka, MD, PhD, Gemini Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PiXLHyperopia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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