PiXL for Correction of Hyperopia

• Sponsor: Gemini Eye Clinic (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03805425
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 51
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperopia	Radiation: PiXL	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

1. Change in Uncorrected Distance Visual Acuity [Month 12]

   Best distance visual acuity tested without any correction

2. Change in Subjective Refraction [Month 12]

   Spherical and cylindrical correction

Secondary Outcome Measures

1. Change in keratometry [Month 12]

   Change in keratomery parameter K2-K1provided by Pentacam

2. Change in Higher Order Aberrations [Month 12]

   Higher Order Aberrations assessed using Pentacam

3. Change in pachymetry [Month 12]

   Change in mean cornea thickness in 8.0 mm ring provided by Pentacam

4. Subjective questionnaire score [Month 12]

   Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.

5. Change in Corrected Distance Visual Acuity [Month 12]

   Best distance visual acuity tested with the best correction

6. Change in Spherical aberration [Month 12]

   Spherical aberration assessed using Pentacam

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gemini Eye Clinic	Zlín		Czechia	760 01

Sponsors and Collaborators

• Gemini Eye Clinic

Investigators

• Principal Investigator: Pavel Stodulka, MD, PhD, Gemini Eye Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Gemini Eye Clinic
• ClinicalTrials.gov Identifier: NCT03805425
• Other Study ID Numbers: PiXLHyperopia
• First Posted: Jan 15, 2019
• Last Update Posted: Feb 3, 2021
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gemini Eye Clinic: Hypeorpia; Crosslinking; PiXL
• Additional relevant MeSH terms: Hyperopia

Study Results

No Results Posted as of Feb 3, 2021