Status:
UNKNOWN
Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software
Lead Sponsor:
CooperVision International Limited (CVIL)
Collaborating Sponsors:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
6-35 years
Phase:
NA
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 comf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Poor personal hygiene
- Aphakia
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05389072
Start Date
June 1 2022
End Date
May 1 2023
Last Update
September 26 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
4S Eyecare and Optometry
San Diego, California, United States, 92127
2
Carillon Vision Care
Glenview, Illinois, United States, 60025
3
Bellaire Family EyeCare
Bellaire, Texas, United States, 77401
4
University Complutense of Madrid
Madrid, Spain