The P.A.U.S.E.® Spectacle Study

Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial

The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are:

Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error?

Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months.

Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 months period.

After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 months period.

The aims of this clinical trial are:

1. To compare the rate of myopia progression as measured by change from the Stage 1 Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the cycloplegic spherical equivalent autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (test-1 and test-2) and single vision spectacle lenses (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test-1, test-2, or control.
2. To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 40 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the cycloplegic spherical equivalent autorefraction while wearing P.A.U.S.E.® spectacle lenses. The myopic children from Stage 1 will enter Stage 2.

The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months.

The visits are:

Stage 1: Baseline, Dispensing, 1-, 6-, 12-months. Stage 2: Dispensing, 6- and 12- months

All procedures performed at these visits are standard, non-invasive clinical tests.

Inclusion Criteria:

• Be between 6-14 years inclusive at time of enrolment.

• Have:

  • Read the Informed Assent.
  • Been explained the Informed Assent.
  • Indicated an understanding of the Informed Assent.
  • Signed the Informed Assent.

• Have their parent / legal guardian:

  • Read the Informed Consent.
  • Been explained the Informed Consent.
  • Indicated an understanding of the Informed Consent.
  • Signed the Informed Consent.

• Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.

• Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.

• Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.

• Be in good general health, based on the parent's / legal guardian's knowledge.

• Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.8) or better in each eye.

• Meet the following criteria determined by cycloplegic autorefraction at Baseline:

  o-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. o-1.50 DC ≤ astigmatic component ≤ 0 DC. o|Spherical equivalent anisometropia| ≤ 1.00 D.

Exclusion Criteria:

• Participant is currently an active participant in another study or was active participant in another study within 30 days prior to this study.

• Current or prior use of interventions intended for myopia control, including but not limited to:

  • Optical devices:

    • Bifocal / multifocal spectacles.
    • Bifocal / multifocal contact lenses.
    • Orthokeratology.

  • Pharmacological agents:

    • Atropine with a concentration > 0.01%.
    • Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
    • Pirenzepine.

• Participant born earlier than 30 weeks or weighed < 1500 g at birth.

  o A verbal report from the participant's parent / legal guardian is sufficient.

• Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.

• A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.

• Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.

• Known ocular or systemic disease, such as but not limited to:

  • Diabetes.
  • Graves' disease.
  • Glaucoma.
  • Uveitis.
  • Scleritis.
  • Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren's syndrome, and systemic lupus erythematosus.

• Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:

  • Persistent pupillary membrane.
  • Vitreous haemorrhage.
  • Cataract.
  • Central corneal scarring.
  • Eyelid haemangiomas.
  • Marfan's syndrome.
  • Down's syndrome.
  • Ehler's-Danlos syndrome.
  • Stickler's syndrome.
  • Ocular albinism.
  • Retinopathy of prematurity.

• Keratoconus or irregular cornea.

• The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.