Acuity 200â„¢ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear (NCT06009458) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Acuity 200â„¢ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
United States387 participantsStarted 2023-10-01
Plain-language summary
The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200â„¢ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).
Who can participate
Age range7 Years
SexALL
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Inclusion criteria
✓. Is age 7 or older with full legal capacity to volunteer or has parental or legal guardian written approval to volunteer; and has read, understood and signed the Informed Consent Form or Assent Form (for subjects 18 years and under);
✓. Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits;
✓. Has naturally occurring refractive myopia from -0.75 to -6.00 diopters sphere (spectacle plane), with refractive astigmatism (spectacle plane) up to 1.75 DC-as determined by adjusted manifest refraction (phoropter or trial frame) with a 12.5 mm vertex distance.
✓. Has a best spectacle corrected visual acuity of 0.04 log MAR (20/20 -2) or better in each eye;
✓. Is free of eye disease and binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) that may affect vision or contact lens wear; Has normal healthy eyes with no evidence of lid infection or structural abnormality; a conjunctiva free of infection; a cornea clear and free of edema, visually or topographically significant scars, clinically significant staining, significant vascularization, infiltrates when examined by slit-lamp biomicroscopy; and no evidence of iritis or uveitis.
Exclusion criteria
✕. Is pregnant, breast-feeding or intends to become pregnant over the course of the study.
✕. Is a potential pediatric subject that does not have the appropriate level of psychological maturity to comply with appropriate procedures needed for safe wear according to the investigator.
✕. Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity.
What they're measuring
1
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
Timeframe: 1 year
2
Attempted vs. Achieved Reduction in manifest refractive error
Timeframe: 1 Year
3
Proportion of eyes achieved UCVA of ≤0.30 logMAR , ≤0.20 logMAR ,≤0.10 logMAR, and ≤0.00 logMAR
Timeframe: 1 Year
4
Treatment stability
Timeframe: 1 Year
5
Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit
Timeframe: 1 Year
6
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
Timeframe: 1 Year
7
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
Timeframe: 1 Year
8
Number and rate of cases of loss from baseline to any post-dispensing visit of: monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
✕. Has a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, specifically excludes subjects from eligibility.
✕. Has a history of intraocular or corneal surgery (including cataract extraction and refractive surgery-such as Lasik), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye. NOTE: This includes any subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any subject with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
✕. Has evidence of keratoconus, corneal irregularity, or abnormal video-keratography in either eye.
✕. Has a pupil size greater than 6.0 mm in photopic illumination as measured with pupil detection component of computer assisted video keratography.