PiXL for Correction of Hyperopia

Gemini Eye Clinic25 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperopia

Interventions

PiXLRADIATION

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gemini Eye Clinic

Zlín, Czechia

Outcomes

Primary Outcomes

Change in Uncorrected Distance Visual Acuity

Best distance visual acuity tested without any correction

Time frame: Month 12

Change in Subjective Refraction

Spherical and cylindrical correction

Time frame: Month 12

Secondary Outcomes

Change in keratometry

Change in keratomery parameter K2-K1provided by Pentacam

Time frame: Month 12

Change in Higher Order Aberrations

Higher Order Aberrations assessed using Pentacam

Time frame: Month 12

Change in pachymetry

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

Time frame: Month 12

Subjective questionnaire score

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

Time frame: Month 12

Change in Corrected Distance Visual Acuity

Best distance visual acuity tested with the best correction

Time frame: Month 12

Change in Spherical aberration

Spherical aberration assessed using Pentacam

Time frame: Month 12

Data from ClinicalTrials.gov

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