Using special spectacle films to slow myopia progression in children

Spectacle Films Utilising A.R.R.E.S.T.® Technology for Slowing Myopia Progression in Vietnamese Children: A Prospective, Controlled, Randomised Clinical Trial

This study is testing if special spectacle films can help slow down the worsening of nearsightedness in children aged 6 to 14 compared to regular glasses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 6 Years to 14 Years
• Sex: All
• Sponsor: nthalmic Pty Ltd (Research network)
• Locations: 1 site (Hà Nội)
• Trial ID: NCT06692699 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of spectacle films utilizing Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) technology in slowing myopia progression in children aged 6 to 14. Participants will be randomly assigned to wear either the A.R.R.E.S.T.® spectacle films or standard single vision lenses. Over a 12-month period, they will attend seven clinic visits to assess changes in axial length and myopic refractive error. The study will compare the outcomes between the two groups to determine if the A.R.R.E.S.T.® technology offers any advantages in managing myopia.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 14 who are experiencing myopia.

Not a fit: Patients with other significant eye conditions or those who cannot comply with the study's wearing schedule 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: While the use of spectacle films is a novel approach, similar studies have shown promise in managing myopia progression with various interventions.

Eligibility criteria

Inclusion Criteria

* Be between 6 to 14 years old 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 to adhere to the study requirements.
* Along with their parent/legal guardian, agree to maintain the visit and prescribed wearing schedule.
* Agree to wear the study spectacles for a minimum of 5 days/week, 6 hours/day for the duration of the study and to inform the investigator if their schedule is interrupted.
* Be in good general health, based on parent's/legal guardian's knowledge.
* Have best-corrected high contrast visual acuity of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.80) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction at Baseline:

  * -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS
  * -1.50 DC ≤ astigmatic component ≤ 0 DC
  * \|Spherical equivalent anisometropia\| ≤ 1.00 D. Exclusion Criteria
* Participant is currently an active participant in another study or was an 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.
* 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, Sjogrens 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

Hà Nội

• Ha Noi Eye Hospital 2 — Hà Nội, Vietnam (Recruiting)

Study contacts

• Study coordinator: Daniel Tilia, PhD

Conditions Myopia; Myopia Progression; axial length