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

NCT05389072 | Unknown FDA Device

• 1 other identifier: SEC-P042021
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Control Lens

EXPERIMENTAL

Device: control contact lens

Interventions

control contact lens DEVICE

control CRT lens

Control Lens

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Are 6- 35 years of age
• Have had a self-reported visual exam in the last two years
• Have a contact lens refraction that fits within the available parameters of the study lenses
• 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.);
• 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;
• Are willing to comply with the wear schedule (8 hour per night for every night, while sleeping)
• Are willing to comply with the visit schedule
• 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
• Have a refractive spherical component ≥ cylinder component
• Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit
• Have clear corneas and no active ocular disease
• 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
• Can be shown to have stable keratometry for at least the previous 1 month, if they have previously worn orthokeratology lenses.

You may not qualify if:

• 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
• 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)
• Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
• Are pregnant, planning a pregnancy or lactating
• Have amblyopia
• Have presbyopia or has dependence on spectacles for near work over the contact lenses
• Present at screening visit with the presence of clinically significant (grade \>3; Efron scale) anterior segment abnormalities.
• Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
• Pathological dry eye or associated findings
• Pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization \> 0.75 mm from of the limbus
• Giant papillary conjunctivitis (GPC) worse than grade 1
• Anterior uveitis or iritis (past or present)
• Seborrheic eczema, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• CooperVision, Inc.: collaborator

Study Sites (4)

4S Eyecare and Optometry

San Diego, California, 92127, United States

RECRUITING

Carillon Vision Care

Glenview, Illinois, 60025, United States

RECRUITING

Bellaire Family EyeCare

Bellaire, Texas, 77401, United States

RECRUITING

University Complutense of Madrid

Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jose Vega, OD

CONTACT

925-621-3761; jvega2@coopervision.com

Kelly Voltz, OD

CONTACT

kvoltz@coopervisionsec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

US (3); ES (1)