Orthokeratology contact lenses with a 5 mm optic zone diameter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-site interventional study evaluates the first-fit success, visual performance, and ocular health of 5 mm optic zone diameter orthokeratology lenses worn overnight. Participants have myopia with astigmatism and meet specific refractive and health criteria. The trial uses a single lens type (paflufocon D) and follows a defined wear and visit schedule to assess clinical outcomes and user-reported experience. Data will focus on lens fitting success, vision quality, and safety over the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

1. Are 6- 35 years of age
2. 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
3. Have had a self-reported visual exam in the last two years
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
5. Are willing to comply with the wear schedule (approximately 8 hours per night for every night, while sleeping)
6. Are willing to comply with the visit schedule
7. 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
8. Have a refractive spherical component ≥ cylinder component
9. Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit
10. Have clear corneas and no active ocular disease.
11. 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
12. 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 report 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; ISO 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

Where it's running

• Treehouse Eyes Pleasanton Center
  Pleasanton, California, United States Recruiting
• Bellaire Family Eye Care
  Bellaire, Texas, United States Recruiting
• Complutense University of Madrid Av.
  Madrid, Moncloa - Aravaca,, Spain Not yet recruiting

Study contacts

• Study coordinator: Kelly Voltz
• Email: KVoltz@coopervision.com
• Phone: +19256604364

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a device for screening vision problems in young children

  This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.

  Recruiting Essilor International · Nancy, France and 1 other locations · NCT06882408

• Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia

  This study tests whether two popular soft multifocal toric contact lenses perform differently in adults who need vision correction for astigmatism and myopia.

  Recruiting CooperVision International Limited (CVIL) · New York, New York and 2 other locations · NCT07829419

• Seeing clearly in low light after Ray-Tracing guided LASIK

  A trial tests how well WaveLight Plus LASIK works for people with myopia and astigmatism and whether patients are satisfied after the procedure.

  Recruiting Phase 4 Vance Thompson Vision · Sioux Falls, South Dakota · NCT07790185

• SMILE in one eye vs Ray tracing-guided LASIK in the fellow eye

  This study tests two laser vision correction methods—SMILE in one eye and ray-tracing guided LASIK in the other eye—to see which provides better vision and quality of life for adults with myopia and astigmatism.

  Recruiting Phase 4 Stanford University · Palo Alto, California · NCT07721714

• Comparing Ray‑Tracing Guided LASIK with three other laser vision correction methods for myopia and astigmatism

  This test will compare Ray‑Tracing Guided LASIK to three other laser or lenticule refractive procedures for adults with moderate myopia, with or without astigmatism.

  Recruiting Hoopes Vision · Draper, Utah · NCT07201298

• WaveLight Plus LASIK for nearsightedness and astigmatism

  This study will try WaveLight Plus LASIK in adults with nearsightedness and astigmatism to see if it improves vision, satisfaction, and quality of life over three months.

  Recruiting Laser Defined Vision · Greensboro, North Carolina · NCT07127757

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.