Hyperopia
Conditions
Keywords
Hypeorpia, Crosslinking, PiXL
Brief summary
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
Detailed description
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.
Interventions
RADIATIONPiXL
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.
Sponsors
Gemini Eye Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq. * astigmatism up to 0.75 Dcyl * corneal thickness above 400 µm * endothelial cell density above 1500 cell/mm2
Exclusion criteria
* any prior corneal surgery or any eye surgery within the last 3 months, * any corneal pathology e.g. corneal scar or dystrophy * unstable refraction * patient not able to understand and sign informed consent * patients with connective tissue disorder or uncontrolled diabetes * pregnant or lactating women * aphakic eyes or pseudophakic eyes without UV blocking IOL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uncorrected Distance Visual Acuity | Month 12 | Best distance visual acuity tested without any correction |
| Change in Subjective Refraction | Month 12 | Spherical and cylindrical correction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Higher Order Aberrations | Month 12 | Higher Order Aberrations assessed using Pentacam |
| Change in pachymetry | Month 12 | Change in mean cornea thickness in 8.0 mm ring provided by Pentacam |
| Change in Spherical aberration | Month 12 | Spherical aberration assessed using Pentacam |
| Change in Corrected Distance Visual Acuity | Month 12 | Best distance visual acuity tested with the best correction |
| Subjective questionnaire score | Month 12 | Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye. |
| Change in keratometry | Month 12 | Change in keratomery parameter K2-K1provided by Pentacam |
Countries
Czechia
Outcome results
None listed