Myopia Clinical Trial
Official title:
Non-invasive Phototherapeutic Intrastromal Corneal Collagen Crosslinking (PiXL) for Low-grade Myopia
To evaluate the improvement in myopic refractive error and the corneal endothelial safety with a corneal crosslinking treatment regimen for mild myopia. The treatment involves a 4-mm central treatment zone in high oxygen environment without corneal epithelial debridement.
The study is designed as a prospective, single-masked intraindividually comparing randomized controlled trial involving healthy volunteers ≥18 years of age of both genders with mild myopia, performed at the Department of Clinical Sciences / Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 23 persons with a myopia of -0.5 to -2.5 diopters (D) and astigmatism of ≤0.75 D. All participants are treated with phototherapeutic intrastromal corneal collagen cross-linking (PiXL) without epithelial debridement (epi-on), after topical riboflavin. For myopia of less than 1.0D, 10 J/cm2 will be used, for higher levels of myopia 15J/cm2 will be used, and the treatment involves continuous delivery of oxygen around the eye using an oxygen mask to achieve an oxygen concentration of ≥90% during treatment. Participants will be 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. Both eyes will be treated during the same visit. Protocol A: UV irradiation in a central 4 mm homogenous zone of the cornea. Protocol B: UV irradiation in a central ring-shaped 4 mm area of the cornea. Patients are randomized utilizing a computer list of unique random numbers between 1 and 23; an even number will be treated with a homogeneous zone in the right eye; an uneven number with a homogeneous zone in the left eye. All patients are informed about the procedures and provide oral and written consent before inclusion in the study. At baseline, before treatment, each eye is evaluated with slit-lamp examination, subjective refraction, determination of uncorrected (UCVA) and best corrected (BSCVA) visual acuities using the LogMAR fast protocol and intraocular pressure (IOP) using Goldmann applanation tonometry. Each eye is photographed using the "25 pictures" program with the Pentacam HR® (Oculus, Inc. Lynnwood, WA) under standardized, mesopic light conditions. Keratometry readings, central corneal thickness and the average corneal densitometry values (corneal light backscatter), expressed as standardized gray scale units, GSU) is determined with the Pentacam HR®. Central corneal endothelial photographs are taken with the Topcon SP-2000P specular microscope (Topcon Europe B.V., Capelle a/d Ijssel, the Netherlands), and the corneal endothelial cell count is calculated from a cluster of 25 cells from each photograph. All the above mentioned investigations are repeated at 1, 3, 6,12 and 24 months after the treatment. At 1 week after treatment, UCVA is registered and a slit-lamp examination, a subjective comparison of discomfort and visual performance in each eye and an autorefractometer measurement are performed. One day after treatment the latter 3 examinations are performed. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04923841 -
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine
|
N/A | |
Active, not recruiting |
NCT04080128 -
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
|
N/A | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Completed |
NCT04604405 -
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
|
N/A | |
Recruiting |
NCT05594719 -
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
|
N/A | |
Completed |
NCT05594732 -
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
|
N/A | |
Completed |
NCT04492397 -
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
|
N/A | |
Completed |
NCT04536571 -
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
|
N/A | |
Completed |
NCT06046209 -
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
|
N/A | |
Recruiting |
NCT06344572 -
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
|
Phase 3 | |
Recruiting |
NCT05611294 -
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
|
N/A | |
Completed |
NCT05656885 -
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
|
N/A | |
Active, not recruiting |
NCT05534022 -
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.
|
N/A | |
Completed |
NCT03934788 -
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT03701516 -
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
|
N/A | |
Completed |
NCT05538754 -
Post-Market Evaluation of the EVO ICL
|
N/A | |
Completed |
NCT03139201 -
Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT02555722 -
Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
|
N/A | |
Not yet recruiting |
NCT06009458 -
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
|
N/A | |
Recruiting |
NCT05548478 -
Corneal Endothelial Cell Injury Induced by Mitomycin-C
|
N/A |