An interventional study of PiXL in Hyperopia, sponsored by Gemini Eye Clinic. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Gemini Eye Clinic · Not applicable, Interventional, and Treatment
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.
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: PiXL
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.
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
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
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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