RecruitingMyopia

MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

Eligible age

8–12 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

Yes

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Answer a few quick questions about your location and health. Takes about a minute.

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About this study

The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.

Sponsor: CooperVision, Inc.

You may qualify if…

✓ 1. Informed Consent and Assent have been completed
✓ 2. Be between 8 and 12 years of age inclusive at the time of enrollment.
✓ 3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
✓ 4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
✓ 5. Anisometropia: ≤ 1.50D SERE.
✓ 6. Astigmatism: ≤ 0.75 D
✓ 7. Free of ocular disease or abnormalities (including any corneal scar)
✓ 8. Currently have good general health.

You may not qualify if…

✕ 1. Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment.
✕ 2. Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day.
✕ 3. Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
✕ 4. Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
✕ Acute and subacute inflammation or infection of the anterior chamber of the eye.
✕ Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
✕ Severe insufficiency of lacrimal secretion (dry eyes).
✕ Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.