EVALUATION OF ORTHOKERATOLOGY LENSES WITH A 5MM OPTIC ZONE DIAMETER

Overview

To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)

Detailed description

Prospective, multi-site, clinical study evaluating the first-fit success, visual performance, and ocular health outcomes of 5mm OZD orthokeratology lenses fit empirically.

Interventions

• Device Lens A (paflufocon D)
  5 minutes of daily wear

Primary outcome measures

• Comfort at 5 Minutes and 1 Month After Final Lens Dispense [Time frame: 5 minutes after insertion]

Eligibility criteria

Inclusion criteria

A person is eligible for inclusion in the study if they:

• Are 6- 35 years of age
• If under 18 years old they are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document
• Have had a self-reported visual exam in the last two years
• 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
• Are willing to comply with the wear schedule (approximately 8 hours 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 lens 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 criteria

• Present at screening visit with the presence of ocular or systemic disease or report 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; ISO scale) anterior segment abnormalities.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Treehouse Eyes Pleasanton Center — Pleasanton
• Bellaire Family Eye Care — Bellaire

Spain · 1 center

• Complutense University of Madrid Av. — Madrid

Identifiers

NCT: NCT07751172 · SEC-26-27

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗