PiXL for Correction of Hyperopia

Not Applicable

• Conditions: Hyperopia
• Interventions: Radiation: PiXL

• Registration Number: NCT03805425
• Lead Sponsor: Gemini Eye Clinic

Brief Summary

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

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Status Verified: 2019-05
• Primary Completion: 2020-12
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photorefractive intrastromal corneal crosslinking (PiXL)	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.

Primary Outcome Measures

Name	Time	Method
Change in Subjective Refraction	Month 12	Spherical and cylindrical correction
Change in Uncorrected Distance Visual Acuity	Month 12	Best distance visual acuity tested without any correction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gemini Eye Clinic; 🇨🇿 Zlín, Czechia