Clinical trial NCT06577948: The P.A.U.S.E.® Spectacle Study
Official title: Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: a Prospective, Masked, Controlled, Randomised, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: axial length
Lead sponsor: nthalmic Pty Ltd
Sponsor class: NETWORK
Collaborators: name: Brighten Optix Corporation
First posted: 2024-08-29
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 compared to single vision spectacle lenses in myopic children. The main questions it aims to answer are:

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

Researchers will compare spectacle lenses using P.A.U.S.E.® technology to a single vision spectacle lens.

Participants will:

Be randomly allocated to wear either spectacle lenses using P.A.U.S.E.® technology or single vision spectacle lenses.

Visit the clinic on five occasions over a 12 month period.

Detailed description: The aim of this clinical trial is to compare the rate of myopia progression as measured by change from the Dispensing visit (up to 26 days from Baseline), in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (tests) 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.

The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months.

The visits are Baseline, Dispensing, 1 month, 6 months, and 12 months.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Axial Length
timeFrame: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
Secondary outcomes:
measure: Cycloplegic spherical equivalent autorefraction
timeFrame: Baseline, then 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).
measure: Visual performance as measured by high contrast visual acuity at 6 m
timeFrame: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
measure: Visual performance as measured by a non validated questionnaire based on a 1-10
timeFrame: 1 month, 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hai Yen Eye Care
Study officials:
affiliation: nthalmic Pty Lyd
name: Daniel Tilia, MOptom, PhD
role: PRINCIPAL_INVESTIGATOR
References: