Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.
Brief Summary: The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset myopia.


Options:
A: Inclusion Criteria:

* Prior to being considered eligible to participate in this study, each subject MUST:

  1. Be between 8 and 12 years of age inclusive at the baseline examination.
  2. Have:

     1. read the Informed Assent,
     2. been given an explanation of the Informed Assent,
     3. indicated an understanding of the Informed Assent and
     4. signed the Informed Assent Form.
  3. Have their parent or legal guardian:

     1. read the Informed Consent,
     2. been given an explanation of the Informed Consent,
     3. indicated an understanding of the Informed Consent and
     4. signed the Informed Consent Form.
  4. Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
  5. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study
  6. Agree to accept either the control or test lens as assigned by the randomisation scheme.
  7. Agree to wear the assigned contact lenses for the duration of the 2 year study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
  8. Possess wearable and visually functional eyeglasses.
  9. Be in good general health, based on his/her and parent's/guardian's knowledge.
  10. Have best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
  11. Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:

      1. Spherical Equivalent Refractive Error (SERE): between -0.75 and -4.00 D inclusive.
      2. Astigmatism: \< -0.75 D
      3. Anisometropia: \< 1.00D

Exclusion Criteria:

* Subjects may not be considered eligible if ANY of the following apply:

  1. Subject has previously or recently worn soft or rigid gas permeable contact lenses, including orthokeratology lenses.
  2. Subject appears to exhibit poor personal hygiene (that in the investigator's opinion might prevent safe contact lens wear).
  3. Subject is currently or prior to this study has been an active participant in another clinical study.
  4. Parent / guardian or close relative is a member, of the office staff, including the investigator(s).
  5. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
  6. Subject was born earlier than 30 weeks or weighed less than 1500g (3.3lb) at birth.
  7. Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
  8. Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state. Such as, but not limited to: long term use of nasal decongestants (for example, pseudoephedrine, phenylephrine), antihistamines (for example, chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methylphenidate).
  9. A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
  10. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
  11. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
  12. Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjogren's syndrome, lupus erythematosus, scleroderma, or diabetes.
  13. Any ocular, systemic or neuro-developmental conditions that could influence refractive development. Such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis eyelid hemangiomas, Marfan's Syndrome, Down's syndrome, Ehler's-Danlos syndrome, Stickler's syndrome, ocular albinism, retinopathy of prematurity.
  14. Keratoconus or an irregular cornea.
  15. Biomicroscope findings that would contraindicate contact lens wear including, but not limited to:

      1. corneal scars within the visual axis
      2. neovascularisation or ghost vessels \> 1.5 mm in from the limbus
      3. Any active anterior segment ocular disease that would contraindicate contact lens wear.
      4. giant papillary conjunctivitis of Grade 2 or worse
      5. allergic or seasonal conjunctivitis (if the study investigator believes it could significantly interfere with maintaining the specified contact lens wearing schedule)
      6. clinically significant (Grade 3 or 4) abnormalities of the anterior segment, lids, conjunctiva, sclera or associated structures.
  16. The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
  17. Have pathological myopia To be eligible to begin the study, a subject must have ALL of the inclusion criteria and NONE of the exclusion criteria present.
B: Inclusion Criteria:

1. Written Informed Consent from parent and assent from child has been obtained
2. Children aged 6 to 12 years
3. Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
4. Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
5. Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
6. Distance vision correctable to logMAR 0.2 or better in both eyes
7. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
8. Normal intraocular pressure of not greater than 21 mmHg
9. Normal ocular health other than myopia
10. In good general health with no history of cardiac or significant respiratory diseases
11. No asthma-requiring medications in the past one year
12. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
13. Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

1. Ocular or systemic diseases which may affect vision or refractive error
2. Any ocular condition wherein topical atropine is contraindicated
3. Defective binocular function or stereopsis
4. Amblyopia or manifest strabismus including intermittent tropia
5. Previous or current use of atropine or pirenzepine
6. Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
C: Inclusion Criteria:

1. The subject must be between 8 and 12 years of age.
2. At least one of the subject's parents or legal guardian must read and understand English or Chinese.
3. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: \<1.50D in each eye.
4. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
5. The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: \< or equal to 1.00D in each eye.
6. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction.
7. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes.
8. The subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
9. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medications (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Anisometropia of greater than 1.00D by cycloplegic refraction.
10. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction.
11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
12. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks.
13. Strabismus in either eye.
14. Pupil or lid abnormality or infection in either eye
15. Central corneal scar in either eye
16. Aphakia in either eye
17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
18. History of participation in prior clinical trials aimed to control myopia progression.
19. Surgically altered eyes, ocular infection of any type, ocular inflammation.
20. An anterior chamber angle grade 2 or narrower by the Van Herrick method
D: Inclusion Criteria:

* 6 to 10 years old
* Myopia: between 0.50 D and 4.00 D in both eyes
* Astigmatism: \<1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
* Anisometropia: ≤ 1.50 D
* Symmetrical corneal topography with corneal toricity \<2.00 D in both eyes
* Agree for randomization

Exclusion Criteria:

* Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
* Any type of strabismus or amblyopia
* Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
* Rigid contact lenses (including orthokeratology lenses) experience
* Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
* Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
* Poor compliance for lens wear or follow-up

Answer: A