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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photorefractive intrastromal corneal crosslinking (PiXL) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiXL | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Uncorrected Distance Visual Acuity | Best distance visual acuity tested without any correction | Month 12 |
| Change in Subjective Refraction | Spherical and cylindrical correction | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in keratometry | Change in keratomery parameter K2-K1provided by Pentacam | Month 12 |
| Change in Higher Order Aberrations | Higher Order Aberrations assessed using Pentacam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, MD, PhD | Gemini Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 760 01 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25506204 | Background | Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014. |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Month 12 |
| Change in pachymetry | Change in mean cornea thickness in 8.0 mm ring provided by Pentacam | Month 12 |
| Subjective questionnaire score | Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye. | Month 12 |
| Change in Corrected Distance Visual Acuity | Best distance visual acuity tested with the best correction | Month 12 |
| Change in Spherical aberration | Spherical aberration assessed using Pentacam | Month 12 |