Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software

As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: control contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Vega, OD; Phone Number: 925-621-3761; Email: jvega2@coopervision.com
• Study Contact Backup: Name: Kelly Voltz, OD; Email: kvoltz@coopervisionsec.com

Study Locations

• Spain
  • Madrid, Spain
    • Not yet recruiting
    • University Complutense of Madrid
    • Contact: Gonzalo Carracedo; Email: jgcarrac@ucm.es
• United States
  • California
    • San Diego, California, United States, 92127
      • Recruiting
      • 4S Eyecare and Optometry
      • Contact: Keith Wan; Phone Number: 858-675-2020; Email: keithmwan@gmail.com
  • Illinois
    • Glenview, Illinois, United States, 60025
      • Recruiting
      • Carillon Vision Care
      • Contact: Andrew Neukirch; Phone Number: 847-657-8787; Email: eyedocdrummer@gmail.com
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Bellaire Family EyeCare
      • Contact: Ashley Tucker, MD
      • Contact: Phone Number: 713-664-8087

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are 6- 35 years of age
2. Have had a self-reported visual exam in the last two years
3. Have a contact lens refraction that fits within the available parameters of the study lenses
4. Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older (Children 6-years of age will not be asked to sign the assent form as per STERLING IRB.);
5. Are under 18 years old and are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
6. Are willing to comply with the wear schedule (8 hour per night for every night, while sleeping)
7. Are willing to comply with the visit schedule
8. Have a refractive spherical component of their prescription between -0.50 and up to -6.00 diopters (inclusive) AND a refractive cylinder of no more than -1.75 diopters
9. Have a refractive spherical component ≥ cylinder component
10. Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit
11. Have clear corneas and no active ocular disease
12. Have no medication, medical condition, or ocular conditions that contraindicate contact wear OR are expected to affect lens comfort or vision across the 1-month study duration, in the opinion of the investigator
13. Can be shown to have stable keratometry for at least the previous 1 month, if they have previously worn orthokeratology lenses.

Exclusion Criteria:

1. Present at screening visit with the presence of ocular or systemic disease or reports the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
2. Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
3. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
4. Are pregnant, planning a pregnancy or lactating
5. Have amblyopia
6. Have presbyopia or has dependence on spectacles for near work over the contact lenses
7. Present at screening visit with the presence of clinically significant (grade >3; Efron scale) anterior segment abnormalities.

8. Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:

   1. Pathological dry eye or associated findings
   2. Pterygium, pinguecula, or corneal scars within the visual axis
   3. Neovascularization > 0.75 mm from of the limbus
   4. Giant papillary conjunctivitis (GPC) worse than grade 1
   5. Anterior uveitis or iritis (past or present)
   6. Seborrheic eczema, Seborrheic conjunctivitis
   7. History of corneal ulcers or fungal infections
   8. Poor personal hygiene
   9. Aphakia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control Lens	Device: control contact lens; control CRT lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses	1 week
Comfort	Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses	1 month

Collaborators and Investigators

• Sponsor: Paragon Vision Sciences
• Collaborators: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SEC-P042021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes