PiXL as a Treatment for Low Grade Myopia

Myopia Clinical Trial

Official title: Evaluation of a Reduced Photorefractive Intrastromal Corneal Crosslinking Illumination Protocol. A Randomized Controlled Trial.

Status Active, not recruiting

Clinical Trial Summary

To assess the improvement in myopia with phototherapeutic intrastromal corneal collagen cross-linking (PiXL) without epithelial debridement (epi-on) in high oxygen environment for low grade myopia. The study compares two 3.5-mm central ring-shaped zone protocols; 10 min illumination time vs 16:40 min illumination time.

Clinical Trial Description

The study design is a prospective, single-masked intraindividually comparing randomized controlled trial, conducted at the Department of Clinical Sciences / Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study includes healthy men and women with low grade myopia, aged between 18-35 years and involves 25 participants with a myopia of -0.50 to -2.5 diopters (D) and astigmatism of ≤0.75D. All participants are treated with phototherapeutic intrastromal corneal collagen cross-linking (PiXL) without epithelial debridement (epi-on), after topical riboflavin. Both eyes are treated and randomized to receive ultraviolet (UV) light according to PiXL Protocol A in one eye and PiXL Protocol B in the other, which is masked to the participant. Throughout the treatment, humidified oxygen is continuously delivered around the eye using an oxygen mask to achieve an oxygen concentration of ≥95 percentage. Prior to inclusion all participants are informed about the procedures and provide oral and written informed consent.

At baseline, each eye is examined with slit-lamp microscopy, subjective refraction, determination of uncorrected (UCVA), low contrast visual acuity at 2.5 percentage and 10 percentage contrast and best corrected (BSCVA) visual acuities using the LogMAR fast protocol and intraocular pressure (IOP) using Goldmann applanation tonometry. Under standardized, mesopic light conditions each eye is evaluated by keratometry readings, central corneal thickness and after treatment also the depth of demarcation lines, extracted from Schemipflug camera measurements, Pentacam HR® (Oculus, Inc. Lynnwood, WA). Central corneal endothelial photographs are taken with the Topcon SP-2000P specular microscope (Topcon Europe B.V., Capelle a/d Ijssel, the Netherlands), from which the corneal endothelial cell count is manually calculated from a cluster of 25 cells from each photograph. Total ocular wavefront is measured with iTrace (Tracey Technologies, Inc.).

All the above mentioned examinations are reassessed at 1, 3, 6 and 12 months after treatment. At 1 day and 1 week after treatment, solely UCVA, Auto refractor measurements, slit-lamp examination and a subjective comparison of discomfort and visual performance in each eye are evaluated. ;

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

• NCT number: NCT04663048
• Study type: Interventional
• Source: Umeå University
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2019
• Completion date: June 17, 2024