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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389072
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
Coopervision, Inc.
Information provided by (Responsible Party):
Paragon Vision Sciences

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.

Condition or disease Intervention/treatment Phase
Myopia Device: control contact lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control Lens Device: control contact lens
control CRT lens




Primary Outcome Measures :
  1. Comfort [ Time Frame: 1 week ]
    Comfort of lenses (VAS 0-10, 0,5 steps) after insertion

  2. Comfort [ Time Frame: 1 month ]
    Comfort of lenses (VAS 0-10, 0,5 steps) after insertion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389072


Contacts
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Contact: Jose Vega, OD 925-621-3761 jvega2@coopervision.com
Contact: Kelly Voltz, OD kvoltz@coopervisionsec.com

Sponsors and Collaborators
Paragon Vision Sciences
Coopervision, Inc.
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Responsible Party: Paragon Vision Sciences
ClinicalTrials.gov Identifier: NCT05389072    
Other Study ID Numbers: SEC-P042021
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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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
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases