PiXL for Correction of Hyperopia

Hyperopia Clinical Trial

Official title:

Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03805425
• Other study ID #: PiXLHyperopia
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 2021

Study information

• Verified date: May 2019
• Source: Gemini Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperopia

Intervention

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.

Locations

Country	Name	City	State
Czechia	Gemini Eye Clinic	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Gemini Eye Clinic

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Uncorrected Distance Visual Acuity	Best distance visual acuity tested without any correction	Month 12
Primary	Change in Subjective Refraction	Spherical and cylindrical correction	Month 12
Secondary	Change in keratometry	Change in keratomery parameter K2-K1provided by Pentacam	Month 12
Secondary	Change in Higher Order Aberrations	Higher Order Aberrations assessed using Pentacam	Month 12
Secondary	Change in pachymetry	Change in mean cornea thickness in 8.0 mm ring provided by Pentacam	Month 12
Secondary	Subjective questionnaire score	Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.	Month 12
Secondary	Change in Corrected Distance Visual Acuity	Best distance visual acuity tested with the best correction	Month 12
Secondary	Change in Spherical aberration	Spherical aberration assessed using Pentacam	Month 12