Using special spectacle lenses to slow myopia progression in children

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

This study is testing if special glasses can help slow down worsening eyesight in children aged 6 to 14 compared to regular glasses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 6 Years to 14 Years
• Sex: All
• Sponsor: nthalmic Pty Ltd (Research network)
• Locations: 1 site (Ho Chi Minh City)
• Trial ID: NCT06577948 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of spectacle lenses utilizing Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology in slowing the progression of myopia in children aged 6 to 14. Participants will be randomly assigned to wear either P.A.U.S.E.® spectacle lenses or standard single vision lenses over a 12-month period. The study will measure changes in axial length and myopic refractive error through standard clinical tests conducted at five scheduled visits. The overall duration of the trial, including follow-up, is expected to be approximately 18 months.

Who should consider this trial

Good fit: Ideal candidates for this study are myopic children aged 6 to 14 who are willing to adhere to the study requirements.

Not a fit: Patients who are not myopic or those who cannot commit to wearing the spectacles as prescribed may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new method to effectively slow down myopia progression in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Other studies have explored various interventions for myopia control, but the specific P.A.U.S.E.® technology approach is relatively novel.

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.

Where this trial is running

Ho Chi Minh City

• Hai Yen Eye Care — Ho Chi Minh City, Vietnam (Recruiting)

Study contacts

• Principal investigator: Daniel Tilia, MOptom, PhD — nthalmic Pty Lyd
• Study coordinator: Daniel Tilia, MOptom, PhD

Conditions Myopia; axial length