PiXL for Correction of Hyperopia
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|ClinicalTrials.gov Identifier: NCT03805425|
Recruitment Status : Enrolling by invitation
First Posted : January 15, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperopia||Radiation: PiXL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Photorefractive intrastromal corneal crosslinking (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.
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 [ Time Frame: Month 12 ]Best distance visual acuity tested without any correction
- Change in Subjective Refraction [ Time Frame: Month 12 ]Spherical and cylindrical correction
- Change in keratometry [ Time Frame: Month 12 ]Change in keratomery parameter K2-K1provided by Pentacam
- Change in Higher Order Aberrations [ Time Frame: Month 12 ]Higher Order Aberrations assessed using Pentacam
- Change in pachymetry [ Time Frame: Month 12 ]Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
- Subjective questionnaire score [ Time Frame: Month 12 ]Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
- Change in Corrected Distance Visual Acuity [ Time Frame: Month 12 ]Best distance visual acuity tested with the best correction
- Change in Spherical aberration [ Time Frame: Month 12 ]Spherical aberration assessed using Pentacam
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805425
|Gemini Eye Clinic|
|Zlín, Czechia, 760 01|
|Principal Investigator:||Pavel Stodulka, MD, PhD||Gemini Eye Clinic|