PiXL for Correction of Hyperopia

Gemini Eye Clinic

Status: Unknown

Conditions: Hyperopia

Treatments: Radiation: PiXL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03805425

PiXLHyperopia

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Photorefractive intrastromal corneal crosslinking (PiXL)

Experimental group

Description:

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.

Treatment:

Radiation: PiXL